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Completed

NCT Number: NCT02731768

Nutrition, Exercise, and Technology for Weight Loss

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Fitbit Zip

Device

Digital body weight scale

Device

Primary outcomes

  1. Change from Baseline Body Weight at 4 and 12 months

    Time frame: 0, 4, and 12 months

Secondary outcomes

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

    Time frame: 0, 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.

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

    Time frame: 2, 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.

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

    Time frame: 0 and 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.

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

    Time frame: 0, 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.

  5. Change from Baseline Social Support Through Technology (2-item questionnaire - level of support and type of support through technology) at 4 and 12 months

    Time frame: 0, 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.

  6. 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

  7. 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

  8. 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 outcomes

  1. Participant Satisfaction (Satisfaction Questionnaire)

    Time frame: 4 and 12 months

  2. Participant Engagement-chat sessions

    Time frame: 0-4 months (all weeks)

    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

  3. Participant Engagement-diet and physical activity

    Time frame: 0-4 months (all weeks)

    Number of days self-monitored diet on MyFitnessPal and physical activity on Fitbit-recorded by investigator

  4. Participant Engagement-weight

    Time frame: 0-4 months (all weeks)

    Number of days self-monitored weight-self-reported via a weekly question on study website

  5. Participant Engagement-log-ins

    Time frame: 0-4 months (all weeks)

    Number of log-ins to study website-objectively tracked via computer

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 8, 2016
Registry last updated
Sep 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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