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Study of Novel Approaches for Prevention (SNAP)

Primary Purpose

Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Small Behavior Changes
Large Behavior Changes
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Weight Gain

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. BMI of 21 - 30 kg/m2

Exclusion Criteria:

  1. Untreated hypertension, hyperlipidemia, or type 2 diabetes, unless permission is provided by their health care provider.
  2. Heart disease, heart problems or report being prescribed drugs for blood pressure or a major heart condition, unless permission is provided by their health care provider.
  3. Type 1 diabetes or treatment of type 2 diabetes with insulin or oral medication that may cause hypoglycemia.
  4. Health problems which may influence the ability to walk for physical activity (e.g. lower limb amputation) or other reasons why a person should not do physical activity, unless permission is provided from their health care provider.
  5. Health problems that may be associated with unintentional weight change or affect the safety of a weight loss program, including report of a heart attack or stroke, chest pain during periods of activity or rest, loss of consciousness, active tuberculosis, HIV, chronic hepatitis B or C, inflammatory bowel disease requiring treatment within the past year, thyroid disease, renal disease, liver disease, hospitalization for asthma in the past year, or cancer within the past 5 years (except for non-melanoma skin cancers or early stage cervical cancer) or chronic use of steroid medication.
  6. Report of a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa) or meet criteria for anorexia or bulimia nervosa during screening for this trial
  7. Report of a past diagnosis of or current symptoms of alcohol or substance dependence.
  8. Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months.
  9. History of schizophrenia, manic depression, or bipolar disorder.
  10. Hospitalization for depression or other psychiatric disorder within the past 12 months.
  11. Having lost and maintained a weight loss of 10 pounds or more within the past 6 months or are currently participating in a weight loss program, trying to gain weight, using steroids for muscle mass or weight gain, taking weight loss medication, or have had surgery for weight loss.
  12. Participation in another weight loss or physical activity study that would interfere with this study.
  13. Another member of the household (or roommate) is a participant or staff member on this trial.
  14. Reason to suspect that the participant would not adhere to the study intervention or assessment schedule (i.e., can't come to group on a regular basis; will be away for more than two weeks during initial intervention phase or planning to move from the area within next year).
  15. Not able to speak and understand English.
  16. Residence or place of work further than 30 miles from the intervention site.
  17. Perceived inability to attend the 2 year data collection visit.
  18. Does not have Internet access on a regular basis.

Sites / Locations

  • University of North Carolina
  • The Miriam Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Small behavior changes

Large behavior changes

Arm Description

"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).

Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).

Outcomes

Primary Outcome Measures

Weight Changes From Baseline Over Follow-up.
Mean weight change from baseline across an average planned follow-up of three years. These mean changes will be compared among the three arms of the trial.

Secondary Outcome Measures

Weight Gain 1 Pound or More at Any Time Over Follow-up
Average over time (average follow-up of 3 years) of the percent of participants within each arm of the trial who gain 1 pound or more at each visit. These percentages will be compared among the three arms generalized estimating equations. Note that weight changes in units of pounds were used to define this outcome so that it may be more clear to participants. Elsewhere in the protocol, weight is reported in kilograms. Percentages at each visit are the percent who gained 1 pound or more from baseline among all who were weighed at that visit. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status.
Mean Weight Changes
Mean differences in weight changes among intervention groups at 24 months post-randomization
Mean Changes in Systolic Blood Pressure
Compare changes in systolic blood pressure across the three intervention groups
Mean Changes From Baseline in Diastolic Blood Pressure
Change from baseline to 2 years in diastolic blood pressure
Mean Changes From Baseline to 2 Years in Total Cholesterol
Mean changes from baseline to 2 years in total cholesterol among participants with Year 2 measurements (mg/dl)
Obesity
Percentage of those participants whose body mass index at baseline was less than 30 kg/m2 who subsequently transitioned to a body mass index of 30 kg/m2 or more (i.e. met criteria for obesity) sometime during 3 years of follow-up (i.e. at least one visit). Percentages will be compared among the three arms of the trial and summarized with odds ratios Participants were assigned values of 0 or 1 at each exam depending on their obesity level. Inference is based on generalized estimating equations.
Dietary Restraint: Mean Change From Baseline to 2 Years
The Eating Inventory (Stunkard, 1988) is a 51-item self-report instrument, was used to assess the subscale of dietary restraint (e.g., degree of conscious control exerted over eating behaviors; range from 0-21 with higher scores reflecting greater levels of restraint). Reference: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.
Disinhibition
The Eating Inventory (TFEQ(Stunkard, 1988), a 51-item self-report instrument, was used to assess the subscale of disinhibition (e.g., susceptibility to loss of control over eating; range 0-16, with higher scores reflecting greater levels of disinhibition). REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.
Flexible Dietary Control
Flexible control is characterized by a balanced approach to eating (e.g., taking smaller portions to control weight, engaging in healthy compensation) and is associated with better weight management outcomes (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 12 with higher scores reflecting greater levels of flexible control. REF: Westenhoefer, J., Stunkard, A. J., & Pudel, V. (1999). Validation of the flexible and rigid control dimensions of dietary restraint. Int J Eat Disord, 26(1), 53-64.
Rigid Dietary Control
Rigid control is characterized by an all-or-nothing inflexibility around dietary rules (e.g., strict calorie counting, with guilt following if calorie-dense foods are consumed) that is associated with poor weight outcomes and more binge eating (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 16 with higher scores reflecting greater rigid control. REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.
General Health Index
The General Health Index, a one-item question from the CDC's Health-Related Quality of Life measure (Measuring Healthy Days, 2000) required participants to report whether in general their health is excellent (1), very good (2), good (3), fair (4), or poor (5). Lower scores denotes better outcomes. Ref: Measuring Healthy Days. (2000). Atlanta, Georgia: Centers for Disease Control and Prevention
Mean Changes in High Density Lipoprotein Cholesterol (HDL-C)
Mean changes in HDL-C from baseline to year 2 in (mg/dl) for compared among the 3 arms using analysis of variance
Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C)
Mean changes between baseline and 2 years in low density lipoprotein cholesterol: LDL-c (mg/dl)
Mean Change in Fasting Glucose From Baseline to 2 Years
Mean change in fasting glucose from baseline to 2 years in mg/dl for all participants with year 2 measures
Mean Change in Fasting Insulin From Baseline to 2 Years
Mean change in fasting insulin (uU/ml) from baseline to 2 years
Depression Symptomatology
Mean changes in the Center for Epidemiologic Studies Depression (CES-C) Scale. Reference: Turvey, C. L., Wallace, R. B., & Herzog, R. (1999). A revised CES-D measure of depressive symptoms and a DSM-based measure of major depressive episodes in the elderly. Int Psychogeriatr, 11(2), 139-148. 20 item questionnaire with a possible range of scores is zero to 60, and higher scores indicating the presence of more symptomatology.
Insulin Resistance
We calculated homeostatic model assessment insulin resistance (HOMA-IR): fasting glucose in (mg/dl) * fasting insulin in (uU/mL).
Total Energy Dietary Intake Per Day (Kcals)
Dietary intake was assessed using the 2005 Block Food Frequency Questionnaire (Block FFQ) at baseline and 2 years. This validated, quantitative 110-food item questionnaire is designed to assess relative intake of energy. REF: Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol 1990; 43:1327-1335.
Change in Waist Circumference (cm)
Waist circumference will be measured using a Gulik tape measure and following a standardized protocol. Two measures of waist circumference will be taken; if the difference exceeds 1.0 cm, a third measure will be taken. Changes are measured from baseline to year 2.
Self-weighing
Number of days per week the participant reports weighing themselves. This is divided into two groups: 1) more than once per week and 2) no more than once per week

Full Information

First Posted
August 13, 2010
Last Updated
January 7, 2020
Sponsor
Wake Forest University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01183689
Brief Title
Study of Novel Approaches for Prevention
Acronym
SNAP
Official Title
Study of Novel Approaches for Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
December 31, 2014 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Study of Novel Approaches for Prevention (SNAP) is randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Two different self-regulation interventions for weight gain prevention will be compared in this trial; one intervention will focus on making small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs, whereas the other will emphasize larger changes in eating and exercise that occur periodically, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gains. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average three-year follow-up differs across the three groups, with the hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group. SNAP-E (Extension) will determine whether the effects of the intervention can be maintained over an additional 3 years (i.e. through a total of 6 years).
Detailed Description
Young adults, aged 20-35 years, experience the greatest rate of weight gain, averaging 1-2 lbs/yr. Over time, this weight gain is associated with a worsening in cardiovascular disease risk factors and an increase in the prevalence of metabolic syndrome. Given the difficulties in producing sustained weight loss later in life, preventing weight gain from occurring during this critical period is key to curbing the obesity epidemic. The Study of Novel Approaches for Prevention (SNAP) is a 2-center randomized trial designed to test whether behavioral interventions based on self-regulation can prevent weight gain in young adults (18-35 years; body mass index (BMI) 21-30 kg/m2). Approximately 600 participants will be recruited over two years and randomly assigned to a control condition (N=200), self-regulation with small changes (N=200) or self-regulation with large changes (N=200). The Small Changes group will be taught to make small, consistent, changes in eating and exercise behavior to prevent weight gain or reverse weight gain if it occurs whereas the Large Changes group will emphasize periodic, larger changes in eating and exercise, with a goal of producing weight loss and thereby providing a buffer against anticipated weight gain. The primary aim of the trial is to test whether the magnitude of weight gain from baseline across an average planned follow-up of three years differs across the three groups, with a priori hypotheses that weight gain will be greater in the Control group than in either intervention and greater in the Small Changes than Large Changes group. Secondary aims are to compare the three groups on a) the proportion of participants in the three groups who gain less than 1 pound over the planned follow-up, b) the mean difference in weight gain from baseline to 24-month follow-up, c) the changes in behaviors and psychosocial measures (diet, physical activity, dietary restraint, frequency of self-weighing,depression, and occurrence of abnormal eating behaviors), and d) the changes in cardiovascular disease risk factors (blood pressure, lipids, insulin sensitivity, and waist circumference). The trial will also examine the association among changes in behaviors, weight, and cardiovascular disease risk factors and examine variables that may moderate the effects of the intervention (including gender, ethnicity, initial BMI, age) and potential mediators of the effects of the intervention (including changes in diet, activity, and self-regulatory behaviors). SNAP is member of the Early Adult Reduction in Weight Through Lifestyle Interventions (EARLY) consortium of clinical trials funded by the National Heart, Lung, and Blood Institute.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
599 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
"Self-Guided Behavior Changes". This group will be used to determine average rate of weight gain over 3 years with little intervention. Participants randomized to this group will receive one face-to-face session that will provide general education of self-weighing and information about both the small and large changes approach. Participants will also be provided with quarterly newsletters describing study events and very limited information on health eating.
Arm Title
Small behavior changes
Arm Type
Experimental
Arm Description
Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate small changes (e.g., modify diet by approximately 100 kcal, decrease portion sizes or change types of food, increase activity by 2000 steps/day).
Arm Title
Large behavior changes
Arm Type
Experimental
Arm Description
Participants randomized to this group will be taught to self-weigh daily and report weights regularly. They will be reinforced for maintaining weight below randomization weight and taught that if weight exceeds randomization weight, they should reinstate large changes (e.g., modify diet to 1200-1500 or 1500-1800 kcal/day with < 30% fat, increase exercise to 250 minutes/week of moderate intensity activity).
Intervention Type
Behavioral
Intervention Name(s)
Small Behavior Changes
Other Intervention Name(s)
Small Behavior Changes plus self-regulation
Intervention Description
The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain. Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time. Exercise: At the start of the program, participants will be given a pedometer and asked to record their current or baseline number of steps. They will then be given the goal of increasing their daily steps by 2000 steps per day over this baseline level.
Intervention Type
Behavioral
Intervention Name(s)
Large Behavior Changes
Other Intervention Name(s)
Large Behavior Changes plus self-regulation
Intervention Description
The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood. Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds. Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes per day) using activities similar in intensity to brisk walking.
Primary Outcome Measure Information:
Title
Weight Changes From Baseline Over Follow-up.
Description
Mean weight change from baseline across an average planned follow-up of three years. These mean changes will be compared among the three arms of the trial.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Weight Gain 1 Pound or More at Any Time Over Follow-up
Description
Average over time (average follow-up of 3 years) of the percent of participants within each arm of the trial who gain 1 pound or more at each visit. These percentages will be compared among the three arms generalized estimating equations. Note that weight changes in units of pounds were used to define this outcome so that it may be more clear to participants. Elsewhere in the protocol, weight is reported in kilograms. Percentages at each visit are the percent who gained 1 pound or more from baseline among all who were weighed at that visit. Participants were assigned values of 0 or 1 at each visit depending on their weight gain status.
Time Frame
3 years
Title
Mean Weight Changes
Description
Mean differences in weight changes among intervention groups at 24 months post-randomization
Time Frame
2 years
Title
Mean Changes in Systolic Blood Pressure
Description
Compare changes in systolic blood pressure across the three intervention groups
Time Frame
Measured at 2 Years
Title
Mean Changes From Baseline in Diastolic Blood Pressure
Description
Change from baseline to 2 years in diastolic blood pressure
Time Frame
2 years
Title
Mean Changes From Baseline to 2 Years in Total Cholesterol
Description
Mean changes from baseline to 2 years in total cholesterol among participants with Year 2 measurements (mg/dl)
Time Frame
2 years
Title
Obesity
Description
Percentage of those participants whose body mass index at baseline was less than 30 kg/m2 who subsequently transitioned to a body mass index of 30 kg/m2 or more (i.e. met criteria for obesity) sometime during 3 years of follow-up (i.e. at least one visit). Percentages will be compared among the three arms of the trial and summarized with odds ratios Participants were assigned values of 0 or 1 at each exam depending on their obesity level. Inference is based on generalized estimating equations.
Time Frame
3 years
Title
Dietary Restraint: Mean Change From Baseline to 2 Years
Description
The Eating Inventory (Stunkard, 1988) is a 51-item self-report instrument, was used to assess the subscale of dietary restraint (e.g., degree of conscious control exerted over eating behaviors; range from 0-21 with higher scores reflecting greater levels of restraint). Reference: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.
Time Frame
2 years
Title
Disinhibition
Description
The Eating Inventory (TFEQ(Stunkard, 1988), a 51-item self-report instrument, was used to assess the subscale of disinhibition (e.g., susceptibility to loss of control over eating; range 0-16, with higher scores reflecting greater levels of disinhibition). REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.
Time Frame
Changes at 2 years
Title
Flexible Dietary Control
Description
Flexible control is characterized by a balanced approach to eating (e.g., taking smaller portions to control weight, engaging in healthy compensation) and is associated with better weight management outcomes (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 12 with higher scores reflecting greater levels of flexible control. REF: Westenhoefer, J., Stunkard, A. J., & Pudel, V. (1999). Validation of the flexible and rigid control dimensions of dietary restraint. Int J Eat Disord, 26(1), 53-64.
Time Frame
Changes from baseline to 2 years
Title
Rigid Dietary Control
Description
Rigid control is characterized by an all-or-nothing inflexibility around dietary rules (e.g., strict calorie counting, with guilt following if calorie-dense foods are consumed) that is associated with poor weight outcomes and more binge eating (Westenhoefer, Stunkard, & Pudel, 1999). Scores range from 0 to 16 with higher scores reflecting greater rigid control. REF: Stunkard, A. J. M., S. (1988). Eating Inventory Manual. New York: Psychological Corporation.
Time Frame
Changes from baseline to 2 years
Title
General Health Index
Description
The General Health Index, a one-item question from the CDC's Health-Related Quality of Life measure (Measuring Healthy Days, 2000) required participants to report whether in general their health is excellent (1), very good (2), good (3), fair (4), or poor (5). Lower scores denotes better outcomes. Ref: Measuring Healthy Days. (2000). Atlanta, Georgia: Centers for Disease Control and Prevention
Time Frame
Changes from baseline to 2 years
Title
Mean Changes in High Density Lipoprotein Cholesterol (HDL-C)
Description
Mean changes in HDL-C from baseline to year 2 in (mg/dl) for compared among the 3 arms using analysis of variance
Time Frame
2 years
Title
Mean Changes in Low Density Lipoprotein Cholesterol (LDL-C)
Description
Mean changes between baseline and 2 years in low density lipoprotein cholesterol: LDL-c (mg/dl)
Time Frame
2 years
Title
Mean Change in Fasting Glucose From Baseline to 2 Years
Description
Mean change in fasting glucose from baseline to 2 years in mg/dl for all participants with year 2 measures
Time Frame
2 years
Title
Mean Change in Fasting Insulin From Baseline to 2 Years
Description
Mean change in fasting insulin (uU/ml) from baseline to 2 years
Time Frame
2 years
Title
Depression Symptomatology
Description
Mean changes in the Center for Epidemiologic Studies Depression (CES-C) Scale. Reference: Turvey, C. L., Wallace, R. B., & Herzog, R. (1999). A revised CES-D measure of depressive symptoms and a DSM-based measure of major depressive episodes in the elderly. Int Psychogeriatr, 11(2), 139-148. 20 item questionnaire with a possible range of scores is zero to 60, and higher scores indicating the presence of more symptomatology.
Time Frame
2 years
Title
Insulin Resistance
Description
We calculated homeostatic model assessment insulin resistance (HOMA-IR): fasting glucose in (mg/dl) * fasting insulin in (uU/mL).
Time Frame
Change from baseline to 2 years
Title
Total Energy Dietary Intake Per Day (Kcals)
Description
Dietary intake was assessed using the 2005 Block Food Frequency Questionnaire (Block FFQ) at baseline and 2 years. This validated, quantitative 110-food item questionnaire is designed to assess relative intake of energy. REF: Block G, Woods M, Potosky A, Clifford C. Validation of a self-administered diet history questionnaire using multiple diet records. J Clin Epidemiol 1990; 43:1327-1335.
Time Frame
Changes from baseline to 2 years in kilocalories
Title
Change in Waist Circumference (cm)
Description
Waist circumference will be measured using a Gulik tape measure and following a standardized protocol. Two measures of waist circumference will be taken; if the difference exceeds 1.0 cm, a third measure will be taken. Changes are measured from baseline to year 2.
Time Frame
Change from baseline to 2 years
Title
Self-weighing
Description
Number of days per week the participant reports weighing themselves. This is divided into two groups: 1) more than once per week and 2) no more than once per week
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
6 Year Weight Changes
Description
Changes from baseline to year 6 in body weight
Time Frame
6 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. BMI of 21 - 30 kg/m2 Exclusion Criteria: Untreated hypertension, hyperlipidemia, or type 2 diabetes, unless permission is provided by their health care provider. Heart disease, heart problems or report being prescribed drugs for blood pressure or a major heart condition, unless permission is provided by their health care provider. Type 1 diabetes or treatment of type 2 diabetes with insulin or oral medication that may cause hypoglycemia. Health problems which may influence the ability to walk for physical activity (e.g. lower limb amputation) or other reasons why a person should not do physical activity, unless permission is provided from their health care provider. Health problems that may be associated with unintentional weight change or affect the safety of a weight loss program, including report of a heart attack or stroke, chest pain during periods of activity or rest, loss of consciousness, active tuberculosis, HIV, chronic hepatitis B or C, inflammatory bowel disease requiring treatment within the past year, thyroid disease, renal disease, liver disease, hospitalization for asthma in the past year, or cancer within the past 5 years (except for non-melanoma skin cancers or early stage cervical cancer) or chronic use of steroid medication. Report of a past diagnosis of or treatment for a Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR) eating disorder (anorexia nervosa or bulimia nervosa) or meet criteria for anorexia or bulimia nervosa during screening for this trial Report of a past diagnosis of or current symptoms of alcohol or substance dependence. Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months. History of schizophrenia, manic depression, or bipolar disorder. Hospitalization for depression or other psychiatric disorder within the past 12 months. Having lost and maintained a weight loss of 10 pounds or more within the past 6 months or are currently participating in a weight loss program, trying to gain weight, using steroids for muscle mass or weight gain, taking weight loss medication, or have had surgery for weight loss. Participation in another weight loss or physical activity study that would interfere with this study. Another member of the household (or roommate) is a participant or staff member on this trial. Reason to suspect that the participant would not adhere to the study intervention or assessment schedule (i.e., can't come to group on a regular basis; will be away for more than two weeks during initial intervention phase or planning to move from the area within next year). Not able to speak and understand English. Residence or place of work further than 30 miles from the intervention site. Perceived inability to attend the 2 year data collection visit. Does not have Internet access on a regular basis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rena Wing, PhD
Organizational Affiliation
The Miriam Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Judy Bahnson
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Lang, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark A Espeland, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah Tate, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Beth Lewis, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27559
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data can be obtained by request, conditional on a data use agreement.
Citations:
PubMed Identifier
35501471
Citation
Corso LML, Wing RR, Tate DF, Espeland MA, Blanchard BE, McCaffery JM. Uric acid as a predictor of weight gain and cardiometabolic health in the Study of Novel Approaches to Weight Gain Prevention (SNAP) study. Int J Obes (Lond). 2022 Aug;46(8):1556-1559. doi: 10.1038/s41366-022-01131-1. Epub 2022 May 2.
Results Reference
derived
PubMed Identifier
31858732
Citation
Wing RR, Espeland MA, Tate DF, Perdue LH, Bahnson J, Polzien K, Robichaud EF, LaRose JG, Gorin AA, Lewis CE, Jelalian E; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Weight Gain Over 6 Years in Young Adults: The Study of Novel Approaches to Weight Gain Prevention Randomized Trial. Obesity (Silver Spring). 2020 Jan;28(1):80-88. doi: 10.1002/oby.22661.
Results Reference
derived
PubMed Identifier
30704533
Citation
LaRose JG, Neiberg RH, Evans EW, Tate DF, Espeland MA, Gorin AA, Perdue L, Hatley K, Lewis CE, Robichaud E, Wing RR; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Dietary outcomes within the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial. Int J Behav Nutr Phys Act. 2019 Jan 31;16(1):14. doi: 10.1186/s12966-019-0771-z.
Results Reference
derived
PubMed Identifier
29956495
Citation
Olson KL, Neiberg RH, Tate DF, Garcia KR, Gorin AA, Lewis CE, Unick J, Wing RR. Weight and Shape Concern Impacts Weight Gain Prevention in the SNAP Trial: Implications for Tailoring Intervention Delivery. Obesity (Silver Spring). 2018 Aug;26(8):1270-1276. doi: 10.1002/oby.22212. Epub 2018 Jun 28.
Results Reference
derived
PubMed Identifier
29699816
Citation
McCaffery JM, Ordovas JM, Huggins GS, Lai CQ, Espeland MA, Tate DF, Wing RR. Weight gain prevention buffers the impact of CETP rs3764261 on high density lipoprotein cholesterol in young adulthood: The Study of Novel Approaches to Weight Gain Prevention (SNAP). Nutr Metab Cardiovasc Dis. 2018 Aug;28(8):816-821. doi: 10.1016/j.numecd.2018.02.018. Epub 2018 Mar 6.
Results Reference
derived
PubMed Identifier
29202850
Citation
Unick JL, Lang W, Williams SE, Bond DS, Egan CM, Espeland MA, Wing RR, Tate DF; SNAP Research Group. Objectively-assessed physical activity and weight change in young adults: a randomized controlled trial. Int J Behav Nutr Phys Act. 2017 Dec 4;14(1):165. doi: 10.1186/s12966-017-0620-x.
Results Reference
derived
PubMed Identifier
28782918
Citation
Wing RR, Tate DF, Garcia KR, Bahnson J, Lewis CE, Espeland MA; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Improvements in Cardiovascular Risk Factors in Young Adults in a Randomized Trial of Approaches to Weight Gain Prevention. Obesity (Silver Spring). 2017 Oct;25(10):1660-1666. doi: 10.1002/oby.21917. Epub 2017 Aug 7.
Results Reference
derived
PubMed Identifier
28116151
Citation
Unick JL, Lang W, Tate DF, Bond DS, Espeland MA, Wing RR. Objective Estimates of Physical Activity and Sedentary Time among Young Adults. J Obes. 2017;2017:9257564. doi: 10.1155/2017/9257564. Epub 2017 Jan 2.
Results Reference
derived
PubMed Identifier
27278474
Citation
Crane MM, LaRose JG, Espeland MA, Wing RR, Tate DF. Recruitment of young adults for weight gain prevention: randomized comparison of direct mail strategies. Trials. 2016 Jun 8;17(1):282. doi: 10.1186/s13063-016-1411-4.
Results Reference
derived
PubMed Identifier
27136493
Citation
Wing RR, Tate DF, Espeland MA, Lewis CE, LaRose JG, Gorin AA, Bahnson J, Perdue LH, Hatley KE, Ferguson E, Garcia KR, Lang W; Study of Novel Approaches to Weight Gain Prevention (SNAP) Research Group. Innovative Self-Regulation Strategies to Reduce Weight Gain in Young Adults: The Study of Novel Approaches to Weight Gain Prevention (SNAP) Randomized Clinical Trial. JAMA Intern Med. 2016 Jun 1;176(6):755-62. doi: 10.1001/jamainternmed.2016.1236.
Results Reference
derived
PubMed Identifier
25865175
Citation
Wing RR, Tate D, LaRose JG, Gorin AA, Erickson K, Robichaud EF, Perdue L, Bahnson J, Espeland MA. Frequent self-weighing as part of a constellation of healthy weight control practices in young adults. Obesity (Silver Spring). 2015 May;23(5):943-9. doi: 10.1002/oby.21064. Epub 2015 Apr 10.
Results Reference
derived
PubMed Identifier
25128185
Citation
Tate DF, LaRose JG, Griffin LP, Erickson KE, Robichaud EF, Perdue L, Espeland MA, Wing RR. Recruitment of young adults into a randomized controlled trial of weight gain prevention: message development, methods, and cost. Trials. 2014 Aug 16;15:326. doi: 10.1186/1745-6215-15-326.
Results Reference
derived
PubMed Identifier
23556505
Citation
Wing RR, Tate D, Espeland M, Gorin A, LaRose JG, Robichaud EF, Erickson K, Perdue L, Bahnson J, Lewis CE. Weight gain prevention in young adults: design of the study of novel approaches to weight gain prevention (SNAP) randomized controlled trial. BMC Public Health. 2013 Apr 4;13:300. doi: 10.1186/1471-2458-13-300.
Results Reference
derived

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Study of Novel Approaches for Prevention

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