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NCT03961061 · ClinicalTrials.gov registry record · NA
Increased Monitoring of Physical Activity and Calories With Technology
A NA study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT03961061: Completed NA study, sponsored by Wake Forest University Health Sciences.
NCT03961061 is a NA study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03961061, a NA study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study Summary
Since severe obesity in youth has been steadily increasing. Specialized pediatric obesity clinics provide programs to aid in reducing obesity. Since the home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during behavioral weight loss interventions, a family-based treatment approach is best. This strategy has been moderately successful in our existing, evidence-based pediatric weight management program, Brenner Families In Training (Brenner FIT). However, since programs such as Brenner Families in Training rely on face-to-face interactions and delivery, they are sometimes by the time constraints experienced by families. Therefore, the purpose of this study is to develop and pilot a tailored, mobile health component to potentially increase the benefits seen by Brenner FIT standard program components and similar pediatric weight management programs.
Primary Outcome
The weight status of youth will be quantified through the calculation of BMI derived from the measurement of height and weight at the intake and follow-up visits. Both height (plus/minus 0.1 cm) and weight(plus/minus 0.5 kg) will be recorded twice, and values will be averaged to produce the final value using a digital scale and a stadiometer. BMI will be calculated as kg/m2. BMI z-score will be calculated using CDC growth charts and converted to BMI-for-age percentile based on CDC growth charts
Interventions
- BEHAVIORAL Brenner mFIT (standard care)
- BEHAVIORAL Brenner mFIT (standard care plus mobile health components)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2022-12-01 |
| Phase | NA |
What the finished NCT03961061 record still lists
NCT03961061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Brenner mFIT (standard care) is the first listed.
NCT03961061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03961061 about?
NCT03961061 is a clinical study titled "Increased Monitoring of Physical Activity and Calories With Technology". Since severe obesity in youth has been steadily increasing. Specialized pediatric obesity clinics provide programs to aid in reducing obesity. Since the home environment and parental behavioral modeling are two of the strongest predictors of child weight loss during behavioral weight loss interventi...
What is the current status of trial NCT03961061?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2020-11-04. Estimated completion is 2022-12-01.
What interventions are being tested in trial NCT03961061?
The interventions under investigation include: Brenner mFIT (standard care) (BEHAVIORAL), Brenner mFIT (standard care plus mobile health components) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03961061?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03961061's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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