Back to resultsCARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss (CARE)
Primary Purpose
Overweight, Obesity
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Energy Reduction
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring weight loss, body weight, behavioral
Eligibility Criteria
Inclusion Criteria:
- Age 21-75
- Body mass index (BMI) 30-50 kg/m2
Exclusion Criteria:
- Uncontrolled hypertension (blood pressure >160/100 mm Hg)
- Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases or orthopedic problems that limit physical activity
- Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, antibiotics for HIV or TB, or chemotherapeutic drugs; prescription weight loss medications (past six months)
- Unwilling or unable to do any of the following: give informed consent; read English at the 5th grade level; accept random assignment; travel to the intervention site
- Likely to relocate out of the area in the next 2 years
- Participation in another randomized research project
- Weight loss > 10 pounds in past six months
- History of bariatric surgery
- Major depressive or psychiatric disorder, or excessive alcohol intake
- Potential participants living farther than 30 miles driving distance from UAB will be excluded from the study.
- Potential participants (female) that are pregnant or plan to become pregnant in the next 18 months will be excluded from participation in the study. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
Sites / Locations
- University of Alabama at Birmingham, Medical Towers Building
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Fixed Energy (or Calorie) Reduction
Variable Energy (or Calorie) Reduction
Arm Description
Participants randomly assigned to this arm will be instructed to reduce their food intake by a moderate amount and stay at this level of moderate reduction until their weight loss goal is achieved.
Participants randomly assigned to this arm will be instructed to alternate between two levels of calorie reduction. One level will be a small amount of calorie reduction, while the other will be a more significant amount of calorie reduction. At the instruction of the research team, participants will periodically alternate back and forth between these two goals until their weight loss goal is achieved.
Outcomes
Primary Outcome Measures
Body weight
change in body weight (kg) from baseline to follow-up assessments
Secondary Outcome Measures
Resting energy expenditure
An indirect calorimeter with the ventilated hood technique will be used for the 30-minute measurement (the first 10 minutes will be excluded from analysis). The respiratory quotient will be calculated as the ratio of carbon dioxide production to oxygen consumption. Resting metabolic rate will be calculated from VO2 and VCO2 measurements using the Weir equation.
Body composition
Assessed by full body DXA scan to evaluate percentage of body fat.
Laboratory analyses
Glucose, lipids, and insulin will be analyzed using blood samples.
Blood pressure
After a 5 minute seated rest, three measurements using an automated blood pressure device will be taken to obtain the average systolic and diastolic blood pressures.
Hormones - ghrelin
Total ghrelin will be assessed using blood samples.
Hormones - leptin
Total leptin will be assessed using blood samples.
Satiety/hunger
Visual analogue scales (VAS) will be used to measure subjective ratings of appetite. Participants will be asked to provide a rating in response to several questions (e.g., "How hungry did you feel this week? How much did you think about food this week?") using a 100-mm line ranging from "not at all" to "extremely".
Energy intake
Participants will be encouraged to utilize web-based and mobile apps for dietary self-monitoring. Energy intake (kcal/day) will be calculated for all daily entries that include at least two eating episodes, defined as the entry of food item(s) and corresponding caloric values. Daily self-monitoring of energy intake will occur up to 365 days between baseline and month 12 time points.
Physical activity - objective
Will be assessed via accelerometers worn by participants for seven days. Participants will be instructed to position the accelerometer at the right hip and to wear the device throughout the day except when sleeping, bathing, or participating in swimming or other water activities. These data will be used to estimate total minutes of moderate- to vigorous-intensity PA.
Physical activity - self-report
Self-reported PA will also be assessed with the Paffenbarger Physical Activity Questionnaire (PPAQ). Both methods of PA measurement are included, as accelerometers provide objective information about total levels of activity, while the PPAQ provides additional details about the type and schedule of activities.
Treatment adherence
Treatment adherence will be assessed by the number of treatment sessions attended as well as the number of self-monitoring forms completed, which have both been used as indicators of adherence in our previous work
Treatment novelty
This construct will be evaluated with a 6-item measure of treatment reinforcement that assesses the extent to which participants enjoy and become less habituated to the behavioral strategies required for weight loss.
Treatment burden
Behavioral burden of treatment will be assessed with a modified version of the Treatment Burden Questionnaire (TBQ), which includes 15 items measuring the burden of treatment, including behaviors of self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships.
Treatment satisfaction
Participants will complete a modified version of the Treatment Satisfaction Questionnaire for Medication (TSQM) to assess attitudes and satisfaction regarding the weight loss intervention, energy prescriptions provided, and weight loss achieved. A composite score of treatment satisfaction will be calculated based on participants' responses.
Side effects
Symptom checklist including minor (e.g., constipation, dry mouth) and more severe events (e.g., cardiovascular events) will be administered to assess potential adverse side effects associated with both treatments.
Full Information
NCT ID
NCT02736669
First Posted
April 4, 2016
Last Updated
September 18, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT02736669
Brief Title
CARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss
Acronym
CARE
Official Title
Fixed Versus Variable Energy Reduction During Behavioral Obesity Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (Actual)
Primary Completion Date
April 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research study will compare two weight loss programs that provide different recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in an effort to determine if fixed calorie reduction or varied calorie reduction is more effective for weight loss.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
weight loss, body weight, behavioral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed Energy (or Calorie) Reduction
Arm Type
Active Comparator
Arm Description
Participants randomly assigned to this arm will be instructed to reduce their food intake by a moderate amount and stay at this level of moderate reduction until their weight loss goal is achieved.
Arm Title
Variable Energy (or Calorie) Reduction
Arm Type
Experimental
Arm Description
Participants randomly assigned to this arm will be instructed to alternate between two levels of calorie reduction. One level will be a small amount of calorie reduction, while the other will be a more significant amount of calorie reduction. At the instruction of the research team, participants will periodically alternate back and forth between these two goals until their weight loss goal is achieved.
Intervention Type
Behavioral
Intervention Name(s)
Energy Reduction
Primary Outcome Measure Information:
Title
Body weight
Description
change in body weight (kg) from baseline to follow-up assessments
Time Frame
6, 12, and 18 months
Secondary Outcome Measure Information:
Title
Resting energy expenditure
Description
An indirect calorimeter with the ventilated hood technique will be used for the 30-minute measurement (the first 10 minutes will be excluded from analysis). The respiratory quotient will be calculated as the ratio of carbon dioxide production to oxygen consumption. Resting metabolic rate will be calculated from VO2 and VCO2 measurements using the Weir equation.
Time Frame
6, 12, and 18 months
Title
Body composition
Description
Assessed by full body DXA scan to evaluate percentage of body fat.
Time Frame
6, 12, and 18 months
Title
Laboratory analyses
Description
Glucose, lipids, and insulin will be analyzed using blood samples.
Time Frame
6, 12, and 18 months
Title
Blood pressure
Description
After a 5 minute seated rest, three measurements using an automated blood pressure device will be taken to obtain the average systolic and diastolic blood pressures.
Time Frame
6, 12, and 18 months
Title
Hormones - ghrelin
Description
Total ghrelin will be assessed using blood samples.
Time Frame
6, 12, and 18 months
Title
Hormones - leptin
Description
Total leptin will be assessed using blood samples.
Time Frame
6, 12, and 18 months
Title
Satiety/hunger
Description
Visual analogue scales (VAS) will be used to measure subjective ratings of appetite. Participants will be asked to provide a rating in response to several questions (e.g., "How hungry did you feel this week? How much did you think about food this week?") using a 100-mm line ranging from "not at all" to "extremely".
Time Frame
6, 12, and 18 months
Title
Energy intake
Description
Participants will be encouraged to utilize web-based and mobile apps for dietary self-monitoring. Energy intake (kcal/day) will be calculated for all daily entries that include at least two eating episodes, defined as the entry of food item(s) and corresponding caloric values. Daily self-monitoring of energy intake will occur up to 365 days between baseline and month 12 time points.
Time Frame
Daily
Title
Physical activity - objective
Description
Will be assessed via accelerometers worn by participants for seven days. Participants will be instructed to position the accelerometer at the right hip and to wear the device throughout the day except when sleeping, bathing, or participating in swimming or other water activities. These data will be used to estimate total minutes of moderate- to vigorous-intensity PA.
Time Frame
6, 12, and 18 months
Title
Physical activity - self-report
Description
Self-reported PA will also be assessed with the Paffenbarger Physical Activity Questionnaire (PPAQ). Both methods of PA measurement are included, as accelerometers provide objective information about total levels of activity, while the PPAQ provides additional details about the type and schedule of activities.
Time Frame
6, 12, and 18 months
Title
Treatment adherence
Description
Treatment adherence will be assessed by the number of treatment sessions attended as well as the number of self-monitoring forms completed, which have both been used as indicators of adherence in our previous work
Time Frame
6, 12, and 18 months
Title
Treatment novelty
Description
This construct will be evaluated with a 6-item measure of treatment reinforcement that assesses the extent to which participants enjoy and become less habituated to the behavioral strategies required for weight loss.
Time Frame
6, 12, and 18 months
Title
Treatment burden
Description
Behavioral burden of treatment will be assessed with a modified version of the Treatment Burden Questionnaire (TBQ), which includes 15 items measuring the burden of treatment, including behaviors of self-monitoring, dietary changes, maintaining physical activity, and the impact of treatment on social relationships.
Time Frame
6, 12, and 18 months
Title
Treatment satisfaction
Description
Participants will complete a modified version of the Treatment Satisfaction Questionnaire for Medication (TSQM) to assess attitudes and satisfaction regarding the weight loss intervention, energy prescriptions provided, and weight loss achieved. A composite score of treatment satisfaction will be calculated based on participants' responses.
Time Frame
6, 12, and 18 months
Title
Side effects
Description
Symptom checklist including minor (e.g., constipation, dry mouth) and more severe events (e.g., cardiovascular events) will be administered to assess potential adverse side effects associated with both treatments.
Time Frame
6, 12, and 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 21-75
Body mass index (BMI) 30-50 kg/m2
Exclusion Criteria:
Uncontrolled hypertension (blood pressure >160/100 mm Hg)
Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported HIV); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases or orthopedic problems that limit physical activity
Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, antibiotics for HIV or TB, or chemotherapeutic drugs; prescription weight loss medications (past six months)
Unwilling or unable to do any of the following: give informed consent; read English at the 5th grade level; accept random assignment; travel to the intervention site
Likely to relocate out of the area in the next 2 years
Participation in another randomized research project
Weight loss > 10 pounds in past six months
History of bariatric surgery
Major depressive or psychiatric disorder, or excessive alcohol intake
Potential participants living farther than 30 miles driving distance from UAB will be excluded from the study.
Potential participants (female) that are pregnant or plan to become pregnant in the next 18 months will be excluded from participation in the study. This is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. Additionally, weight loss is not recommended for pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gareth R Dutton, PhD
Organizational Affiliation
University of Alabama at Birmingham, Department of Medicine, Division of Preventive Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham, Medical Towers Building
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The PI will ensure all publications that result from project-related data will comply with the NIH public access policy and develop a system by which study data may be shared with other investigators within the scientific community. With UAB IRB permission, PI may develop a de-identified database, codebook, and mechanism by which data can be shared with qualified individuals/organizations. PI will keep a record of all individuals/res. teams who request/receive a copy of the data. Interested investigators will be asked to complete a request form stating specific aims of the analyses, analytic plan, available resources, proposed timeline, and goals. PI and team will review these requests to determine whether proposed analyses constitute significant exploration of the data, team has resources to complete request, and data will be adequately protected and managed. If any issues are problematic, PI and team will attempt to negotiate a fair resolution with investigators and NIH staff.
Learn more about this trial
CARE Trial: Comparing Different Levels of Calorie Reduction for Weight Loss
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