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Nutrition, Exercise, and Technology for Weight Loss

Primary Purpose

Overweight, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard
Social support-enhanced
Fitbit Zip
Digital body weight scale
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard

Social support-enhanced

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline Body Weight at 4 and 12 months

Secondary Outcome Measures

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.
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.
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.
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.
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.
Change from Baseline Average Daily Step Counts measured via BodyMedia SenseWear armband (one-week time period) at 4 and 12 months
Change from Baseline in Social Support for Eating Habits (Social Support for Eating Habits Scale) at 4 and 12 months
Change from Baseline in Social Support for Weight Loss (Social Support for Weight Loss Scale) at 4 and 12 months

Full Information

First Posted
February 23, 2016
Last Updated
September 17, 2018
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT02731768
Brief Title
Nutrition, Exercise, and Technology for Weight Loss
Official Title
Using Technology to Enhance Social Support for Weight Loss in Adults: The NETworks (Nutrition, Exercise, and Technology) Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Social support-enhanced
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social support-enhanced
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Fitbit Zip
Intervention Type
Device
Intervention Name(s)
Digital body weight scale
Primary Outcome Measure Information:
Title
Change from Baseline Body Weight at 4 and 12 months
Time Frame
0, 4, and 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Social Support for Exercise (Social Support for Exercise Scale) at 4 and 12 months
Description
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.
Time Frame
0, 4, and 12 months
Title
Change from 2-month Autonomy Support (Important Other Climate Questionnaire) at 4 and 12 months
Description
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.
Time Frame
2, 4, and 12 months
Title
Change from Baseline Motivation for Weight Control (Treatment Self-regulation Questionnaire) at 4 months
Description
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.
Time Frame
0 and 4 months
Title
Change from Baseline Appropriate and Inappropriate Weight Control Practices (Weight Control Practices Checklist) at 4 and 12 months
Description
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.
Time Frame
0, 4, and 12 months
Title
Change from Baseline Social Support Through Technology (2-item questionnaire - level of support and type of support through technology) at 4 and 12 months
Description
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.
Time Frame
0, 4, and 12 months
Title
Change from Baseline Average Daily Step Counts measured via BodyMedia SenseWear armband (one-week time period) at 4 and 12 months
Time Frame
0, 4, and 12 months
Title
Change from Baseline in Social Support for Eating Habits (Social Support for Eating Habits Scale) at 4 and 12 months
Time Frame
0, 4, and 12 months
Title
Change from Baseline in Social Support for Weight Loss (Social Support for Weight Loss Scale) at 4 and 12 months
Time Frame
0, 4, and 12 months
Other Pre-specified Outcome Measures:
Title
Participant Satisfaction (Satisfaction Questionnaire)
Time Frame
4 and 12 months
Title
Participant Engagement-chat sessions
Description
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
Time Frame
0-4 months (all weeks)
Title
Participant Engagement-diet and physical activity
Description
Number of days self-monitored diet on MyFitnessPal and physical activity on Fitbit-recorded by investigator
Time Frame
0-4 months (all weeks)
Title
Participant Engagement-weight
Description
Number of days self-monitored weight-self-reported via a weekly question on study website
Time Frame
0-4 months (all weeks)
Title
Participant Engagement-log-ins
Description
Number of log-ins to study website-objectively tracked via computer
Time Frame
0-4 months (all weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Monroe, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will only be reported in aggregate.

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Nutrition, Exercise, and Technology for Weight Loss

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