ObesitymFITNCT02361151
The mFIT Study (Motivating Families With Interactive Technology)
A study testing TECH and TECH+ in people with Obesity, run by University of South Carolina at 1 site in United States.
Trial summary
The high rates of childhood obesity in the US demand innovative and cost-effective weight gain prevention tools; mobile applications (apps) represent one such solution. Using a randomized design, the mFIT study tests the effectiveness of using commercially available apps and a physical activity (PA) monitoring device… Read more about this study
- Who is it for?
- Ages 9 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- TECH and TECH+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2015
- 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 9 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants must include 1 child (age 9-12) and their parent or guardian
- Parent not currently meeting physical activity guidelines (participants will be eligible if they currently engage in aerobic activities for less than 2 hours and 30 minutes/week and strength training <2 days/week)
- Own and use a smartphone and/or a tablet with a data plan (e.g., iPhone, iPad)
- Live in the same household as the child
- Are willing to be randomized to one of the two intervention groups
- Willing and able to be physically active
Who cannot join
- Has a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
- Has an eating disorder
- Currently participating in a weight loss program or taking weight loss medications
- Has a major chronic diseases, including: heart disease, past incidence of stroke, uncontrolled diabetes
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: Enhancing Parent-Child Communication and Promoting Physical Activity and Healthy Eating Through Mobile Technology: the mFIT Study (Motivating Families With Interactive Technology)
The high rates of childhood obesity in the US demand innovative and cost-effective weight gain prevention tools; mobile applications (apps) represent one such solution. Using a randomized design, the mFIT study tests the effectiveness of using commercially available apps and a physical activity (PA) monitoring device (Tech, n=50 parent-child dyads) compared to the apps and PA device plus a mobile website and theory-based family intervention that encourages increased parent-child communication about PA and healthy eating as well as family behavior change (Tech+, n=50 parent-child dyads).
Read the detailed description
Objectives and Significance. Finding scalable and engaging ways to disseminate obesity treatment and prevention for children has been challenging. Mobile applications (apps) are an engaging way to involve children in health behavior changes, capitalizing on the portability and affordability of delivering health information via mobile devices and the opportunity to use gaming to make health information entertaining. Previous research by our team, including a systematic review of commercially available mobile apps for family weight loss, physical activity, and healthy eating as well as a pilot test of commercially available apps and physical activity monitoring devices with parent-child dyads, revealed significant gaps in the available mobile tools. The proposed study will test the effectiveness of using commercially available apps and a physical activity monitoring device (Tech) compared to the apps and physical activity device plus a mobile website and theory-based family intervention that encourages increased parent-child communication about physical activity and healthy eating and family behavior change (Tech+). The two programs will be administered remotely via email, mobile apps, and a mobile website to parent-child dyads (child 9-12 years old), using over a 3-month intervention period. Parent-child dyads will be randomized to the two behavioral interventions: Tech (50 dyads) or Tech+ (50 dyads). Our proposed research has two aims:
Aim 1: Test the effectiveness of an evidence-based mobile intervention with enhanced parent/child communication (Tech+) versus commercially available products (physical activity and healthy eating apps, physical activity device) alone (Tech) for improvements in physical activity and healthy eating in parents and children.
Aim 2: Examine the impacts of evidence-based family intervention on parent-child relationship quality and communication about physical activity and healthy eating.
- Conditions
- Obesity
- Being tested
- TECH, TECH+
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECHBehavioural
Weekly newsletter with health information, mobile apps, and self-monitoring materials
TECH+Behavioural
Weekly newsletter with health information, mobile apps, and self-monitoring materials along with theory-based mobile web intervention
| Study group | Role | What they receive |
|---|---|---|
| TECH (standard program) | Active comparator | Receive 3-month healthy eating and physical activity intervention delivered via email newsletters and mobile apps plus self-monitoring with paper records; based on standard behavior change recommendations and materials (e.g., Diabetes Prevention Program)
Intervention: remotely-delivered evidence-based intervention to support healthy eating and physical activity; use of supporting app-based games and activities and self-monitoring. Receives: Behavioral: TECH |
| TECH+ (enhanced program) | Experimental | Receive 3-month family-based healthy eating and physical activity intervention delivered via email newsletters and mobile apps plus self-monitoring with special study website
Intervention: remotely-delivered evidence-based intervention to support healthy eating and physical activity; use of supporting app-based games and activities; enhanced self-monitoring and family activities via special study website Receives: Behavioral: TECH+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bouts of moderate-to-vigorous physical activity (via accelorometers)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brie Turner-McGrievy, University of South Carolina
- Investigators
- Gabrielle Turner-McGrievy, PhD, MS, RD, Study chair, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361151
- Sponsor's protocol ID
- Pro00038855
- Acronym
- mFIT
- Status last verified
- Apr 2019
- First submitted
- 3 Feb 2015
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Parent-Child Communication and Promoting Physical Activity and Healthy Eating Through Mobile Technology: the mFIT Study (Motivating Families With Interactive Technology)
- ClinicalTrials.gov ID
- NCT02361151
- Acronym / sponsor ID
- mFIT / Pro00038855
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Feb 2015 (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 high rates of childhood obesity in the US demand innovative and cost-effective weight gain prevention tools; mobile applications (apps) represent one such solution. Using a randomized design, the mFIT study tests the effectiveness of using commercially available apps and a physical activity (PA) monitoring device (Tech, n=50 parent-child dyads) compared to the apps and PA device plus a mobile website and theory-based family intervention that encourages increased parent-child communication about PA and healthy eating as well as family behavior change (Tech+, n=50 parent-child dyads).
Detailed description
Objectives and Significance. Finding scalable and engaging ways to disseminate obesity treatment and prevention for children has been challenging. Mobile applications (apps) are an engaging way to involve children in health behavior changes, capitalizing on the portability and affordability of delivering health information via mobile devices and the opportunity to use gaming to make health information entertaining. Previous research by our team, including a systematic review of commercially available mobile apps for family weight loss, physical activity, and healthy eating as well as a pilot test of commercially available apps and physical activity monitoring devices with parent-child dyads, revealed significant gaps in the available mobile tools. The proposed study will test the effectiveness of using commercially available apps and a physical activity monitoring device (Tech) compared to the apps and physical activity device plus a mobile website and theory-based family intervention that encourages increased parent-child communication about physical activity and healthy eating and family behavior change (Tech+). The two programs will be administered remotely via email, mobile apps, and a mobile website to parent-child dyads (child 9-12 years old), using over a 3-month intervention period. Parent-child dyads will be randomized to the two behavioral interventions: Tech (50 dyads) or Tech+ (50 dyads). Our proposed research has two aims:
Aim 1: Test the effectiveness of an evidence-based mobile intervention with enhanced parent/child communication (Tech+) versus commercially available products (physical activity and healthy eating apps, physical activity device) alone (Tech) for improvements in physical activity and healthy eating in parents and children.
Aim 2: Examine the impacts of evidence-based family intervention on parent-child relationship quality and communication about physical activity and healthy eating.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TECH (standard program) | Active comparator | Behavioral: TECHReceive 3-month healthy eating and physical activity intervention delivered via email newsletters and mobile apps plus self-monitoring with paper records; based on standard behavior change recommendations and materials (e.g., Diabetes Prevention Program) Intervention: remotely-delivered evidence-based intervention to support healthy eating and physical activity; use of supporting app-based games and activities and self-monitoring. |
| TECH+ (enhanced program) | Experimental | Behavioral: TECH+Receive 3-month family-based healthy eating and physical activity intervention delivered via email newsletters and mobile apps plus self-monitoring with special study website Intervention: remotely-delivered evidence-based intervention to support healthy eating and physical activity; use of supporting app-based games and activities; enhanced self-monitoring and family activities via special study website |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must include 1 child (age 9-12) and their parent or guardian
- Parent not currently meeting physical activity guidelines (participants will be eligible if they currently engage in aerobic activities for less than 2 hours and 30 minutes/week and strength training <2 days/week)
- Own and use a smartphone and/or a tablet with a data plan (e.g., iPhone, iPad)
- Live in the same household as the child
- Are willing to be randomized to one of the two intervention groups
Key exclusion criteria (4 listed)
- Has a psychiatric disease, drug or alcohol dependency, or uncontrolled thyroid condition
- Has an eating disorder
- Currently participating in a weight loss program or taking weight loss medications
- Has a major chronic diseases, including: heart disease, past incidence of stroke, uncontrolled diabetes
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 |
|---|---|---|
| TECHWeekly newsletter with health information, mobile apps, and self-monitoring materials | Behavioural | TECH (standard program) |
| TECH+Weekly newsletter with health information, mobile apps, and self-monitoring materials along with theory-based mobile web intervention | Behavioural | TECH+ (enhanced program) |
Primary outcome
Bouts of moderate-to-vigorous physical activity (via accelorometers)
Time frame: 12 weeks
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 Apr 2019.
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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.
Gabrielle Turner-McGrievy, PhD, MS, RD study chair
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 TECH and TECH+ in people with 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 4 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 Apr 2019. 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?
Bouts of moderate-to-vigorous physical activity (via accelorometers) (time frame: 12 weeks). 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 Apr 2019.