Nutrition, Exercise, and Technology for Weight Loss

Sponsor
University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT02731768
Collaborator
(none)
36
1
2
13
2.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Standard
  • Behavioral: Social support-enhanced
  • Device: Fitbit Zip
  • Device: Digital body weight scale
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Using Technology to Enhance Social Support for Weight Loss in Adults: The NETworks (Nutrition, Exercise, and Technology) Pilot Randomized Controlled Trial
Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Feb 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard

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
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.

Device: Fitbit Zip

Device: Digital body weight scale

Experimental: Social support-enhanced

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
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.

Device: Fitbit Zip

Device: Digital body weight scale

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline Body Weight at 4 and 12 months [0, 4, and 12 months]

Secondary Outcome Measures

  1. Change from Baseline in Social Support for Exercise (Social Support for Exercise Scale) at 4 and 12 months [0, 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.

  2. Change from 2-month Autonomy Support (Important Other Climate Questionnaire) at 4 and 12 months [2, 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.

  3. Change from Baseline Motivation for Weight Control (Treatment Self-regulation Questionnaire) at 4 months [0 and 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.

  4. Change from Baseline Appropriate and Inappropriate Weight Control Practices (Weight Control Practices Checklist) at 4 and 12 months [0, 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.

  5. Change from Baseline Social Support Through Technology (2-item questionnaire - level of support and type of support through technology) at 4 and 12 months [0, 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.

  6. 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]

  7. 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]

  8. 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]

Other Outcome Measures

  1. Participant Satisfaction (Satisfaction Questionnaire) [4 and 12 months]

  2. Participant Engagement-chat sessions [0-4 months (all weeks)]

    Number of chat sessions attended - recorded by investigator; number of days self-monitored diet on MyFitnessPal and physical activity on Fitbit - recorded by investigator; number of days self-monitored weight - self-reported via a weekly question on study website; number of log-ins to study website - objectively tracked via computer

  3. Participant Engagement-diet and physical activity [0-4 months (all weeks)]

    Number of days self-monitored diet on MyFitnessPal and physical activity on Fitbit-recorded by investigator

  4. Participant Engagement-weight [0-4 months (all weeks)]

    Number of days self-monitored weight-self-reported via a weekly question on study website

  5. Participant Engagement-log-ins [0-4 months (all weeks)]

    Number of log-ins to study website-objectively tracked via computer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Carolina Columbia South Carolina United States 29208

Sponsors and Collaborators

  • University of South Carolina

Investigators

  • Principal Investigator: Courtney Monroe, PhD, University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of South Carolina
ClinicalTrials.gov Identifier:
NCT02731768
Other Study ID Numbers:
  • 1205
First Posted:
Apr 8, 2016
Last Update Posted:
Sep 18, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 18, 2018