Nutrition, Exercise, and Technology for Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731768
• Other study ID #: 1205
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 2017

Study information

• Verified date: September 2018
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

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.
• 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

• Digital body weight scale

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant Satisfaction (Satisfaction Questionnaire)		4 and 12 months
Other	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)
Other	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)
Other	Participant Engagement-weight	Number of days self-monitored weight-self-reported via a weekly question on study website	0-4 months (all weeks)
Other	Participant Engagement-log-ins	Number of log-ins to study website-objectively tracked via computer	0-4 months (all weeks)
Primary	Change from Baseline Body Weight at 4 and 12 months		0, 4, and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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