Clinical trial NCT02731768: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of South Carolina
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from Baseline Body Weight at 4 and 12 months
timeFrame: 0, 4, and 12 months
Secondary outcomes:
measure: Change from Baseline in Social Support for Exercise (Social Support for Exercise Scale) at 4 and 12 months
timeFrame: 0, 4, and 12 months
measure: Change from 2-month Autonomy Support (Important Other Climate Questionnaire) at 4 and 12 months
timeFrame: 2, 4, and 12 months
measure: Change from Baseline Motivation for Weight Control (Treatment Self-regulation Questionnaire) at 4 months
timeFrame: 0 and 4 months
measure: Change from Baseline Appropriate and Inappropriate Weight Control Practices (Weight Control Practices Checklist) at 4 and 12 months
timeFrame: 0, 4, and 12 months
measure: Change from Baseline Social Support Through Technology (2-item questionnaire - level of support and type of support through technology) at 4 and 12 months
timeFrame: 0, 4, and 12 months
measure: Change from Baseline Average Daily Step Counts measured via BodyMedia SenseWear armband (one-week time period) at 4 and 12 months
timeFrame: 0, 4, and 12 months
measure: Change from Baseline in Social Support for Eating Habits (Social Support for Eating Habits Scale) at 4 and 12 months
timeFrame: 0, 4, and 12 months
measure: Change from Baseline in Social Support for Weight Loss (Social Support for Weight Loss Scale) at 4 and 12 months
timeFrame: 0, 4, and 12 months
Other outcomes:
measure: Participant Satisfaction (Satisfaction Questionnaire)
timeFrame: 4 and 12 months
measure: Participant Engagement-chat sessions
timeFrame: 0-4 months (all weeks)
measure: Participant Engagement-diet and physical activity
timeFrame: 0-4 months (all weeks)
measure: Participant Engagement-weight
timeFrame: 0-4 months (all weeks)
measure: Participant Engagement-log-ins
timeFrame: 0-4 months (all weeks)
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Courtney Monroe, PhD
role: PRINCIPAL_INVESTIGATOR
References: