OverweightNCT02731768
Nutrition, Exercise, and Technology for Weight Loss
A study testing Standard, Social support-enhanced and Fitbit Zip in people with Overweight and Obesity, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Standard, Social support-enhanced and Fitbit Zip
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: Using Technology to Enhance Social Support for Weight Loss in Adults: The NETworks (Nutrition, Exercise, and Technology) Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Standard, Social support-enhanced, Fitbit Zip, Digital body weight scale
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandardBehavioural
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-enhancedBehavioural
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 ZipDevice
Digital body weight scaleDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Social support-enhanced; Device: Fitbit Zip; Device: Digital body weight scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Body Weight at 4 and 12 months
Measured: 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
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.
Measured: 0, 4, and 12 months
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.
Measured: 2, 4, and 12 months
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.
Measured: 0 and 4 months
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.
Measured: 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
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.
Measured: 0, 4, and 12 months
Change from Baseline Average Daily Step Counts measured via BodyMedia SenseWear armband (one-week time period) at 4 and 12 months
Measured: 0, 4, and 12 months
Change from Baseline in Social Support for Eating Habits (Social Support for Eating Habits Scale) at 4 and 12 months
Measured: 0, 4, and 12 months
Change from Baseline in Social Support for Weight Loss (Social Support for Weight Loss Scale) at 4 and 12 months
Measured: 0, 4, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Courtney Monroe, PhD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731768
- Sponsor's protocol ID
- 1205
- Status last verified
- Sep 2018
- First submitted
- 23 Feb 2016
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will only be reported in aggregate.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technology to Enhance Social Support for Weight Loss in Adults: The NETworks (Nutrition, Exercise, and Technology) Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02731768
- Acronym / sponsor ID
- 1205
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Behavioral: Standard, Device: Fitbit Zip, Device: Digital body weight scaleParticipants 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 | Experimental | Behavioral: Social support-enhanced, Device: Fitbit Zip, Device: Digital body weight scaleParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StandardParticipants 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. | Behavioural | Standard |
| Social support-enhancedParticipants 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. | Behavioural | Social support-enhanced |
| Fitbit Zip | Device | Social support-enhanced, Standard |
| Digital body weight scale | Device | Social support-enhanced, Standard |
Primary outcome
Change from Baseline Body Weight at 4 and 12 months
Time frame: 0, 4, and 12 months
8 secondary outcomes
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
Change from 2-month Autonomy Support (Important Other Climate Questionnaire) at 4 and 12 months
Time frame: 2, 4, and 12 months
Change from Baseline Motivation for Weight Control (Treatment Self-regulation Questionnaire) at 4 months
Time frame: 0 and 4 months
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
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 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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
- Individual participant dataSharing planned: No. Data will only be reported in aggregate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Monroe, PhD principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard, Social support-enhanced and Fitbit Zip in people with Overweight and Obesity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Body Weight at 4 and 12 months (time frame: 0, 4, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.