Nutrition, Exercise, and Technology for Weight Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Standard; Device: Fitbit Zip; Device: Digital body weight scale; Behavioral: Social support-enhanced

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Device: Fitbit Zip; Device: Digital body weight scale; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction (Satisfaction Questionnaire)		4 and 12 months
Participant Engagement-chat sessions	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	0-4 months (all weeks)
Participant Engagement-diet and physical activity	Number of days self-monitored diet on MyFitnessPal and physical activity on Fitbit-recorded by investigator	0-4 months (all weeks)
Participant Engagement-weight	Number of days self-monitored weight-self-reported via a weekly question on study website	0-4 months (all weeks)
Participant Engagement-log-ins	Number of log-ins to study website-objectively tracked via computer	0-4 months (all weeks)

Collaborators and Investigators

• Sponsor: University of South Carolina

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: February 23, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (ESTIMATE): April 8, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss; Overweight
• Other Study ID Numbers: 1205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will only be reported in aggregate.