Lifestyle Behavior Weight Loss Intervention

Not Applicable

Completed

Conditions: Weight Loss
Obesity

Interventions: Behavioral: Goal-oriented episodic future thinking

Registration Number: NCT04649047

Lead Sponsor: Ohio State University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Goal-oriented episodic future thinking	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

Primary Outcome Measures

Name	Time	Method
Change in Body Weight	baseline (T1) and 3 weeks follow up (T2)	Self-reported body weight

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	baseline (T1) and 3 weeks follow up (T2)	kg/m\^2
Daily Dietary Fat Intake	baseline (T1) and 3 weeks follow up (T2)	NCI brief dietary fat intake survey was used to measure dietary fat intake. Participants reported the frequency of each specific food eaten 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.There is no minimum or maximum available for this measure. The following procedures were used to convert an individual's responses to an estimate of that individual's percentage energy from fat: The frequency reported categorically on the questionnaire was converted to the number of times fat was consumed per day as shown below. In general, the midpoint of the frequency range was used. Never 0.0 Less than once a month 0.018 1-3 times per month 0.066 1-2 times per week 0.214 3-4 times per week 0.499 5-6 times per week 0.784 1. time per day 1.0 2. or more times per day 2.0
Change in Emotion Regulation	baseline (T1) and 3 weeks follow up (T2)	Emotional control. To measure emotional control, we used the Emotion Regulation Questionnaire to assess the emotional regulatory process using reappraisal (6 items) and suppression (4 items). Participants rated the degree of agreement using a 7-point scale: 1 (strongly disagree) to 7 (strongly agree). The suppression items were reverse coded prior to score computation. We summed responses to the 10 items to create a score for emotional control. Scores could range between 10 - 70. Higher scores meant better emotional control.
Daily Fruit and Vegetable Intake	baseline (T1) and 3 weeks follow up (T2)	NCI brief Fruit and Vegetable intake survey was used to measure dietary intake. Participants reported the frequency of each specific food eaten 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 fruit and vegetable intake.There is no minimum or maximum available for this measure. The frequency reported categorically on the questionnaire was converted to the number of times fruits/vegetables were consumed per day as shown below. In general, the midpoint of the frequency range was used. Frequency ResponseTimes Per Day Never 0.0 Less than once a month 0.018 1-3 times per month 0.066 1-2 times per week 0.214 3-4 times per week 0.499 5-6 times per week 0.784 1. time per day 1.0 2. or more times per day 2.0
Frequency of Added Sugar Intake	baseline (T1) and 3 weeks follow up (T2)	NCI brief Added Sugar intake survey was used to measure dietary intake. Participants reported the frequency of each specific food eaten 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.There is no minimum or maximum available for this measure. The frequency reported categorically on the questionnaire was converted to the number of times consumed per day as shown below. In general, the midpoint of the frequency range was used. Frequency ResponseTimes Per Day Never 0.0 Less than once a month 0.018 1-3 times per month 0.066 1-2 times per week 0.214 3-4 times per week 0.499 5-6 times per week 0.784 1. time per day 1.0 2. or more times per day 2.0
Daily Physical Activity (Metabolic Equivalent Task MET)	baseline (T1) and 3 weeks follow up (T2)	The International Physical Activity Questionnaire Short Form (7 items) was be used to measure physical activity. Participants are asked to report frequency (days/week) and duration (hours/ day or minutes/day) of vigorous and moderate physical activities performed in the past 7 days. Participants were asked about 3 specific types of activity: walking, moderate-intensity activity, and vigorous-intensity activity. Participants also reported frequency (days per week) and duration (time per day) for each specific type of activity. To create metabolic equivalent of task (MET, energy expenditure) measures, we multiplied frequency by duration (in hours). We then used the summation times 3.3 MET (walking), 4.0 (moderate physical activity), and 8.0 (vigorous physical activity) to generate physical activity scores in MET units. Higher scores indicated more energy expenditure.
Change in Autonomous Motivation for Stress Management	baseline (T1) and 3 weeks follow up (T2)	Autonomous motivation. To measure autonomous motivation, we used the Treatment Self-Regulation Questionnaire (6 items for stress management). Participants rated how true each statement was for them related to stress management using a 7-point scale: 1 (not at all true) to 7 (very true). We summed responses to the 6 items to create a score for stress management. Scores can range from 6 - 42. Higher scores indicated higher autonomous motivation.
Change in Autonomous Motivation for Healthy Eating	baseline (T1) and 3 weeks follow up (T2)	Autonomous motivation. To measure autonomous motivation, we used the Treatment Self-Regulation Questionnaire (6 items for healthy eating). Participants rated how true each statement was for them related to healthier eating using a 7-point scale: 1 (not at all true) to 7 (very true). We summed responses to the 6 items to create a score for healthy eating. Scores can range from 6 - 42 Higher scores indicated higher autonomous motivation.
Change in Autonomous Motivation for Physical Activity	baseline (T1) and 3 weeks follow up (T2)	Autonomous motivation. To measure autonomous motivation, we used the Treatment Self-Regulation Questionnaire (6 items for physical activity). Participants rated how true each statement was for them related to physical activity using a 7-point scale: 1 (not at all true) to 7 (very true). We summed responses to the 6 items to create a score for physical activity. Scores can range from 6 -42. Higher scores indicated higher autonomous motivation.
Change in General Self-efficacy	baseline (T1) and 3 weeks follow up (T2)	Self-efficacy. We used surveys to measure self-efficacy. We also used the general self-efficacy scale (10 items) to measure self-efficacy. Participants rated the truthfulness of each statement using a 4-point scale: 1 (not at all true) to 4 (exactly true). We summed responses to the 10 items to create a score for general self-efficacy. Scores can range from 10 - 40. Higher scores meant higher self-efficacy.
Change in Healthy Eating Self-efficacy	baseline (T1) and 3 weeks follow up (T2)	Self-efficacy. We used surveys to measure self-efficacy for healthy eating (8 items). Participants rated levels of confidence using a 4-point scale: 1 (not at all confident) to 4 (very confident). We summed responses to the 8 items to create a score for self-efficacy for healthy eating. THigher scores meant higher self-efficacy. Participants rated the truthfulness of each statement using a 4-point scale: 1 (not at all true) to 4 (exactly true). We summed responses to the 10 items to create a score for general self-efficacy. Scores can range from 8 - 32. Higher scores meant higher self-efficacy.
Change in Physical Activity Self-efficacy	baseline (T1) and 3 weeks follow up (T2)	Self-efficacy. We used surveys to measure physical activity (10 items). Participants rated levels of confidence using a 4-point scale: 1 (not at all confident) to 4 (very confident). We summed responses to the 10 items to create a score for self-efficacy for physical activity. Higher scores meant higher self-efficacy. Participants rated the truthfulness of each statement using a 4-point scale: 1 (not at all true) to 4 (exactly true). We summed responses to the 10 items to create a score for general self-efficacy. Scores can range from 10 - 40. Higher scores meant higher self-efficacy.
Change in Perceived Stress	baseline (T1) and 3 weeks follow up (T2)	We used the Perceived Stress Scale (10 items) to measure stress. Participants rated the frequency of stressful life situations in the past month using a 4-point scale: 1 (never) to 4 (often). We summed responses to the 10 items to create a score for stress. Scores can range from 10-40. Higher scores meant perceived higher levels of stress.