Nutrition, Exercise, and Technology for Weight Loss

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether a social support-enhanced, technology-based, behavioral weight control intervention can improve weight loss over existing best practices.

Detailed Description
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This 4-month randomized controlled trial is designed to investigate the short-term efficacy and feasibility of a novel, social support-enhanced behavioral weight control intervention. Participants will be recruited via email listservs, fliers, and word of mouth. They will be randomized to a standard behavioral weight control treatment (SBT) or a social support-enhanced behavioral weight control treatment which receives the same intervention as SBT plus social support resources (specifically, additional self-monitoring technologies) for weight loss.

Official Title
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Using Technology to Enhance Social Support for Weight Loss in Adults: The NETworks (Nutrition, Exercise, and Technology) Pilot Randomized Controlled Trial

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: Standard
* Behavioral: Social support-enhanced
* Device: Fitbit Zip
* Device: Digital body weight scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) between 25 kg/m2 and 55 kg/m2 Age 18 years or older Access to a computer with an Internet connection Smartphone ownership (Android or iOS) Willing to be randomized to either one of the two study groups Only one member of the same household eligible to participate Exclusion Criteria: Currently lactating, pregnant, or planning to become pregnant during the length of the study Been diagnosed with type 1 or type 2 diabetes Medical or physical contraindications or limitations for engaging in physical activity History of major medical or psychiatric conditions Recent changes in medication known to affect weight Schedule that would prohibit or restrict attendance at a designated time for weekly in- person group meetings Currently participating in a weight management program Currently on medication that might affect weight loss

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard<br>Participants will receive an evidence-based behavioral weight control program focused on physical activity and reducing caloric intake. They will be provided with a Fitbit Zip and digital body weight scale for self-monitoring of physical activity and body weight, respectively. They will track caloric intake via the MyFitnessPal smartphone application. They will have access to a study website and attend weekly, in-person group counseling sessions. | Behavioral: Standard<br>* Participants will receive an evidence-based behavioral weight control program focused on physical activity and reducing caloric intake. They will be provided with a Fitbit Zip and digital body weight scale for self-monitoring of physical activity and body weight, respectively.They will track caloric intake via the MyFitnessPal smartphone application. They will have access to a study website and attend weekly, in-person group counseling sessions.<br>Device: Fitbit Zip<br> <br> Device: Digital body weight scale<br> <br> |
| Experimental: Social support-enhanced<br>Participants will receive the same intervention components as the Standard group, as well as two extra Fitbit Zips and digital body weight scales to share with up to two persons in their social circle who will be invited to serve as their support partners. | Behavioral: Social support-enhanced<br>* Participants will receive the same intervention components as the Standard group.Participants will also be provided with two extra Fitbit Zips and digital body weight scales to share with up to two persons in their social circle who will be invited to serve as their support partners.<br>Device: Fitbit Zip<br> <br> Device: Digital body weight scale<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Body Weight at 4 and 12 months |  | 0, 4, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Social Support for Exercise (Social Support for Exercise Scale) at 4 and 12 months | Item scores will be averaged for each respective scale, yielding a final score for each participant. Change in average scores on each scale for each group will be computed. | 0, 4, and 12 months | 
| Change from 2-month Autonomy Support (Important Other Climate Questionnaire) at 4 and 12 months | Item scores will be averaged for the questionnaire, yielding a final score for each participant. Change in average scores for each group will be computed. | 2, 4, and 12 months | 
| Change from Baseline Motivation for Weight Control (Treatment Self-regulation Questionnaire) at 4 months | Item scores will be averaged for the questionnaire on three subscales (autonomous, controlled, and amotivation), yielding a final score for each subscale for each participant. Change in average scores on each subscale for each group will be computed. | 0 and 4 months | 
| Change from Baseline Appropriate and Inappropriate Weight Control Practices (Weight Control Practices Checklist) at 4 and 12 months | Total number of reported appropriate and inappropriate weight control practices will be computed for each participant. Change in the mean number of reported appropriate and inappropriate weight control practices for each group will be computed. | 0, 4, and 12 months | 
| Change from Baseline Social Support Through Technology (2-item questionnaire - level of support and type of support through technology) at 4 and 12 months | Change in average score on level of support obtained through technology for each group will be computed. Change in the type of support obtained through technology will be described using frequency counts and percentages for each group. | 0, 4, and 12 months | 
| Change from Baseline Average Daily Step Counts measured via BodyMedia SenseWear armband (one-week time period) at 4 and 12 months |  | 0, 4, and 12 months | 
| Change from Baseline in Social Support for Eating Habits (Social Support for Eating Habits Scale) at 4 and 12 months |  | 0, 4, and 12 months | 
| Change from Baseline in Social Support for Weight Loss (Social Support for Weight Loss Scale) at 4 and 12 months |  | 0, 4, and 12 months |