Nutrition, Exercise, and Technology for Weight Loss

NCT02731768 | Completed

• 1 other identifier: 1205
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Body Weight at 4 and 12 months

  0, 4, and 12 months

Secondary Outcomes (8)

• Change from Baseline in Social Support for Exercise (Social Support for Exercise Scale) at 4 and 12 months

  0, 4, and 12 months

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

  2, 4, and 12 months

• Change from Baseline Motivation for Weight Control (Treatment Self-regulation Questionnaire) at 4 months

  0 and 4 months

• Change from Baseline Appropriate and Inappropriate Weight Control Practices (Weight Control Practices Checklist) at 4 and 12 months

  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

  0, 4, and 12 months

Other Outcomes (5)

• Participant Satisfaction (Satisfaction Questionnaire)

  4 and 12 months

• Participant Engagement-chat sessions

  0-4 months (all weeks)

• Participant Engagement-diet and physical activity

  0-4 months (all weeks)

Study Arms (2)

Standard

ACTIVE COMPARATOR

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; Device: Fitbit Zip; Device: Digital body weight scale

Social support-enhanced

EXPERIMENTAL

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; Device: Fitbit Zip; Device: Digital body weight scale

Interventions

Standard BEHAVIORAL

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.

Standard

Social support-enhanced BEHAVIORAL

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.

Social support-enhanced

Fitbit Zip DEVICE

Social support-enhanced; Standard

Digital body weight scale DEVICE

Social support-enhanced; Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Courtney Monroe, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: April 8, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)