Lifestyle Behavior Weight Loss Intervention
Primary Purpose
Obesity, Weight Loss
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Goal-oriented episodic future thinking
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring low-income women, weight loss
Eligibility Criteria
Inclusion Criteria:
- Body mass index of 25.0-39.9 kg/m2 (calculated using height and weight)
- Current enrollment in government assistant programs (for example, WIC, food stamp (SNAP), or Madicaid)
- 6 weeks - 3.5 years postpartum
- 18-45 years old
- Fluency in speaking, reading, and writing English
- Ownership of a smart phone with unlimited text messages and internet access
- Committed to a three-week intervention study
Exclusion Criteria:
- Current pregnancy or lactation
- Plan to become pregnant during the trial
- Type 1 or 2 diabetes
- Untreated thyroid disease
- Drug or alcohol abuse or dependence within last six months
- Major psychiatric disorder (e.g., schizophrenia, bipolar)
- History of bulimia or anorexia
- Current taking of appetite suppressant or (antipsychotic) medications known to affect body weight
- Current participation in a weight control or drug study
- Current or planned participation in a commercial weight loss program
- Previous weight loss surgery
- Contraindications to physical activity
Sites / Locations
- The Ohio State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Outcomes
Primary Outcome Measures
Change in body weight
Self-reported body weight
Secondary Outcome Measures
Waist circumference
Self-reported pants size will be used to measure waist circumference. Participants will report their current pants size. Values are: 00-0 = extra small, 2-4 = small, 6-8 = medium, 10-12 = large,14-16 = extra large, 18-20 = 2XL, 22-24 =3XL. Higher scores indicate higher waist circumference.
Change in dietary fat intake
The NCI brief dietary fat intake survey (16 items) will be used to measure dietary fat intake. Participants will be asked to report the frequency of each specific food that they eat over the past 12 months. Values are:1 = never, 2 = less than once per month,3 = 1-3 times per week, 4 = 3-4 times per week,5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 or more times per day. Higher scores indicate more frequent fat intake.
Change in fruit and vegetable intake
The NCI brief fruit and vegetable intake survey (9 items) will be used to measure fruit and vegetable intake. Participants will be asked to report frequency of each specific fruit and vegetable that they eat over the past month. Values are:1 = never, 2 = 1-3 times last month,3 = 1-2 times per week, 4 = 3-4 times per week, 5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 times per day, 8 = 3 times per day, 9 = 4 times per day, 10 = 5 or more times per day. Higher scores indicate more frequent fruit and vegetable intake.
Change in added sugar intake
The NCI five-factor screener (4 items) will be used to measure added sugar intake. Participants will be asked to report frequency of each specific soda beverages that they drink over the past month. Values are:1 = never, 2 = 1-3 times last month,3 = 1-2 times per week, 4 = 3-4 times per week, 5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 times per day, 8 = 3 times per day, 9 = 4 times per day, 10 = 5 or more times per day. Higher scores indicate more frequent added sugar intake.
Change in physical activity
The International Physical Activity Questionnaire Short Form (7 items) will be used to measure physical activity. Participants will be asked to report frequency (days/week) and duration (hours/ day or minutes/day) of vigorous and moderate physical activities that they did in the past 7 days. Higher scores indicate more physical activity.
Change in autonomous motivation for stress management
The Treatment Self-Regulation Questionnaire (6 items) will be used to measure autonomous motivation for stress management. Participants will be asked to report why they manage stress.
Values ranged from 1 to 7: 1 = not at all true, 4 = somewhat true, 7 = very true. Higher scores indicate higher autonomous motivation for stress management.
Change in autonomous motivation for healthy eating
The Treatment Self-Regulation Questionnaire (6 items) will be used to measure autonomous motivation for healthy eating. Participants will be asked to report why they eat healthier foods.
Values ranged from 1 to 7: 1 = not at all true, 4 = somewhat true, 7 = very true. Higher scores indicate higher autonomous motivation for healthy eating.
Change in autonomous motivation for physical activity
The Treatment Self-Regulation Questionnaire (6 items) will be used to measure autonomous motivation for physical activity. Participants will be asked to report why they want to be physically active. Values ranged from 1 to 7: 1 = not at all true, 4 = somewhat true, 7 = very true. Higher scores indicate higher autonomous motivation for physical activity.
Change in coping self-efficacy
Survey for coping self-efficacy (10 items) will be used to measure coping self-efficacy. Participants will be asked to report their confidence in coping stress. Values are 1 = not at all confident, 2 = not too confident, 3 =somewhat confident, 4= very confident. Higher scores indicate higher coping self-efficacy.
Change in healthy eating self-efficacy
Survey for healthy eating self-efficacy (8 items) will be used to measure healthy eating self-efficacy. Participants will be asked to report their confidence in eating healthier. Values are 1 = not at all confident, 2 = not too confident, 3 =somewhat confident, 4= very confident.
Higher scores indicate higher healthy eating self-efficacy.
Change in physical activity self-efficacy
Survey for healthy eating self-efficacy (10 items) will be used to measure physical activity self-efficacy. Participants will be asked to report their confidence in more physically active. Values are 1 = not at all confident, 2 = not too confident, 3 =somewhat confident, 4= very confident. Higher scores indicate higher physical activity self-efficacy.
Change in social support for stress management
A survey (6 items) will be used to measure social support for stress management. The survey assess how often participants asking for family members, friends, co-worker or other people for support when they need it. Values are 1 = rarely or never, 2 = sometimes, 3 = often, 4= usually or always. Higher scores indicate more social support for stress management.
Change in social support for healthy eating
A survey (5 items) will be used to measure social support for healthy eating. The survey assess how often participants asking for family members, friends, co-worker or other people for support they they need it. Values are 1 = rarely or never, 2 = sometimes, 3 = often, 4= usually or always. Higher scores indicate more social support for healthy eating.
Change in social support for physical activity
A survey (4 items) will be used to measure social support for healthy eating. The survey assess how often participants asking for family members, friends, co-worker or other people for support they they need it. Values are 1 = rarely or never, 2 = sometimes, 3 = often, 4= usually or always. Higher scores indicate more social support for physical activity.
Change in emotion regulation
Emotion Regulation Questionnaire (10 items) will be used to assess emotion regulation. This questionnaire assess emotion regulatory process using reappraisal, suppression and regulating negative emotion. The questionnaire has 2 sub scales: reappraisal (6 items) and suppression (4 items). Values are 1 = strongly disagree, 2 = mostly disagree, 3 =somewhat disagree, 4= neither agree or disagree, 5 = somewhat agree, 6 = mostly agree, 7 = strongly agree. Higher scores indicate higher reappraisal or suppression.
Change in perceived stress
The perceived stress scale (10 items) will be used to measure perceived stress. This survey measures the degree to which situations in one's life are appraised as stressful.
Values are 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4= very often Higher scores indicate higher levels of perceived stress.
Change in impulsiveness
The Barratt Impulsiveness scale (30 items) will be used to measure impulsiveness. This survey measures the degree to which situations in one's life are appraised as stressful.
Values are 1 = never, 2 = rarely, 3 = almost always, 4= always. Higher scores indicate less impulsiveness.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04649047
Brief Title
Lifestyle Behavior Weight Loss Intervention
Official Title
Weight Loss Intervention for Mothers With Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This lifestyle behavior intervention aims to weight loss in low-income overweight or obese mothers of young children through promotion of stress management, healthy eating, and physical activity. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions.
Detailed Description
Previous research in lifestyle behavior weight loss intervention has 3 limitations. (1) Low-income overweight or obese mothers of young children have been significantly underrepresented. (2) Prior lifestyle interventions in overweight or obese mothers have suffered from threats to internal validity and have not specifically addressed motivation, emotion, and cognition (especially executive function), all of which are critical for promoting and maintaining healthy lifestyle behaviors and health outcomes. (3) There has been little evidence that any of the potentially efficacious strategies researched previously were even possible under real-world conditions. The proposed small pilot study builds on strength and effectively addresses limitations of prior research. The ultimate goal of the proposed study is to create a more feasible and scalable intervention that can be easily implemented and sustained in real-world settings. This self-directed, web-based goal-oriented episodic future thinking intervention will focus on increasing motivation (autonomous motivation and self-efficacy) and improving emotion (emotion control and stress) and cognition (impulsivity). the will lead to weight loss and decrease risk of chronic conditions associated with obesity, for example, hypertension, type 2 diabetes, and cancer. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions. We will enroll 30 low-income overweight or obese mothers of young children with diverse racial and ethnic backgrounds. All participants will be assessed at baseline (T1) and immediately after the three-week intervention (T2). Specific aims are to to (1) assess intervention fidelity (dose, delivery, receipt) and acceptability by the study participants, (2) investigate potential intervention impact on the primary (body weight) and secondary outcomes (waist circumference), (3) explore potential intervention impact on lifestyle behaviors (diet and physical activity), (4) explore potential intervention impact on motivation (autonomous motivation, self-efficacy, social support), emotion (emotion control, stress), and cognition (impulsivity), and (5) assess cost of different recruitment approaches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
low-income women, weight loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity
Intervention Type
Behavioral
Intervention Name(s)
Goal-oriented episodic future thinking
Intervention Description
All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
Primary Outcome Measure Information:
Title
Change in body weight
Description
Self-reported body weight
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Secondary Outcome Measure Information:
Title
Waist circumference
Description
Self-reported pants size will be used to measure waist circumference. Participants will report their current pants size. Values are: 00-0 = extra small, 2-4 = small, 6-8 = medium, 10-12 = large,14-16 = extra large, 18-20 = 2XL, 22-24 =3XL. Higher scores indicate higher waist circumference.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in dietary fat intake
Description
The NCI brief dietary fat intake survey (16 items) will be used to measure dietary fat intake. Participants will be asked to report the frequency of each specific food that they eat over the past 12 months. Values are:1 = never, 2 = less than once per month,3 = 1-3 times per week, 4 = 3-4 times per week,5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 or more times per day. Higher scores indicate more frequent fat intake.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in fruit and vegetable intake
Description
The NCI brief fruit and vegetable intake survey (9 items) will be used to measure fruit and vegetable intake. Participants will be asked to report frequency of each specific fruit and vegetable that they eat over the past month. Values are:1 = never, 2 = 1-3 times last month,3 = 1-2 times per week, 4 = 3-4 times per week, 5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 times per day, 8 = 3 times per day, 9 = 4 times per day, 10 = 5 or more times per day. Higher scores indicate more frequent fruit and vegetable intake.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in added sugar intake
Description
The NCI five-factor screener (4 items) will be used to measure added sugar intake. Participants will be asked to report frequency of each specific soda beverages that they drink over the past month. Values are:1 = never, 2 = 1-3 times last month,3 = 1-2 times per week, 4 = 3-4 times per week, 5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 times per day, 8 = 3 times per day, 9 = 4 times per day, 10 = 5 or more times per day. Higher scores indicate more frequent added sugar intake.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in physical activity
Description
The International Physical Activity Questionnaire Short Form (7 items) will be used to measure physical activity. Participants will be asked to report frequency (days/week) and duration (hours/ day or minutes/day) of vigorous and moderate physical activities that they did in the past 7 days. Higher scores indicate more physical activity.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in autonomous motivation for stress management
Description
The Treatment Self-Regulation Questionnaire (6 items) will be used to measure autonomous motivation for stress management. Participants will be asked to report why they manage stress.
Values ranged from 1 to 7: 1 = not at all true, 4 = somewhat true, 7 = very true. Higher scores indicate higher autonomous motivation for stress management.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in autonomous motivation for healthy eating
Description
The Treatment Self-Regulation Questionnaire (6 items) will be used to measure autonomous motivation for healthy eating. Participants will be asked to report why they eat healthier foods.
Values ranged from 1 to 7: 1 = not at all true, 4 = somewhat true, 7 = very true. Higher scores indicate higher autonomous motivation for healthy eating.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in autonomous motivation for physical activity
Description
The Treatment Self-Regulation Questionnaire (6 items) will be used to measure autonomous motivation for physical activity. Participants will be asked to report why they want to be physically active. Values ranged from 1 to 7: 1 = not at all true, 4 = somewhat true, 7 = very true. Higher scores indicate higher autonomous motivation for physical activity.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in coping self-efficacy
Description
Survey for coping self-efficacy (10 items) will be used to measure coping self-efficacy. Participants will be asked to report their confidence in coping stress. Values are 1 = not at all confident, 2 = not too confident, 3 =somewhat confident, 4= very confident. Higher scores indicate higher coping self-efficacy.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in healthy eating self-efficacy
Description
Survey for healthy eating self-efficacy (8 items) will be used to measure healthy eating self-efficacy. Participants will be asked to report their confidence in eating healthier. Values are 1 = not at all confident, 2 = not too confident, 3 =somewhat confident, 4= very confident.
Higher scores indicate higher healthy eating self-efficacy.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in physical activity self-efficacy
Description
Survey for healthy eating self-efficacy (10 items) will be used to measure physical activity self-efficacy. Participants will be asked to report their confidence in more physically active. Values are 1 = not at all confident, 2 = not too confident, 3 =somewhat confident, 4= very confident. Higher scores indicate higher physical activity self-efficacy.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in social support for stress management
Description
A survey (6 items) will be used to measure social support for stress management. The survey assess how often participants asking for family members, friends, co-worker or other people for support when they need it. Values are 1 = rarely or never, 2 = sometimes, 3 = often, 4= usually or always. Higher scores indicate more social support for stress management.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in social support for healthy eating
Description
A survey (5 items) will be used to measure social support for healthy eating. The survey assess how often participants asking for family members, friends, co-worker or other people for support they they need it. Values are 1 = rarely or never, 2 = sometimes, 3 = often, 4= usually or always. Higher scores indicate more social support for healthy eating.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in social support for physical activity
Description
A survey (4 items) will be used to measure social support for healthy eating. The survey assess how often participants asking for family members, friends, co-worker or other people for support they they need it. Values are 1 = rarely or never, 2 = sometimes, 3 = often, 4= usually or always. Higher scores indicate more social support for physical activity.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in emotion regulation
Description
Emotion Regulation Questionnaire (10 items) will be used to assess emotion regulation. This questionnaire assess emotion regulatory process using reappraisal, suppression and regulating negative emotion. The questionnaire has 2 sub scales: reappraisal (6 items) and suppression (4 items). Values are 1 = strongly disagree, 2 = mostly disagree, 3 =somewhat disagree, 4= neither agree or disagree, 5 = somewhat agree, 6 = mostly agree, 7 = strongly agree. Higher scores indicate higher reappraisal or suppression.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in perceived stress
Description
The perceived stress scale (10 items) will be used to measure perceived stress. This survey measures the degree to which situations in one's life are appraised as stressful.
Values are 0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4= very often Higher scores indicate higher levels of perceived stress.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
Title
Change in impulsiveness
Description
The Barratt Impulsiveness scale (30 items) will be used to measure impulsiveness. This survey measures the degree to which situations in one's life are appraised as stressful.
Values are 1 = never, 2 = rarely, 3 = almost always, 4= always. Higher scores indicate less impulsiveness.
Time Frame
baseline (T1) and 3 weeks follow up (T2)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participants must be a mother young children
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index of 25.0-39.9 kg/m2 (calculated using height and weight)
Current enrollment in government assistant programs (for example, WIC, food stamp (SNAP), or Madicaid)
6 weeks - 3.5 years postpartum
18-45 years old
Fluency in speaking, reading, and writing English
Ownership of a smart phone with unlimited text messages and internet access
Committed to a three-week intervention study
Exclusion Criteria:
Current pregnancy or lactation
Plan to become pregnant during the trial
Type 1 or 2 diabetes
Untreated thyroid disease
Drug or alcohol abuse or dependence within last six months
Major psychiatric disorder (e.g., schizophrenia, bipolar)
History of bulimia or anorexia
Current taking of appetite suppressant or (antipsychotic) medications known to affect body weight
Current participation in a weight control or drug study
Current or planned participation in a commercial weight loss program
Previous weight loss surgery
Contraindications to physical activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei-Wei Chang, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lifestyle Behavior Weight Loss Intervention
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