Adults 13 to 18, any sex, with Weight Change, Body or Behavior, Health. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
BMI PercentilePrimary· Baseline
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 for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less t
Group
Value
95% CI
Brenner FIT (Standard Care)
98.46
± 2.39
Brenner mFIT (Standard Care Plus Mobile Health Components)
99.37
± .53
BMI PercentilePrimary· 6 months
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 for children and teens ages 2 through 19. According to the CDC, a child with a BMI percentile less t
Group
Value
95% CI
Brenner FIT (Standard Care)
99
± 1.27
Brenner mFIT (Standard Care Plus Mobile Health Components)
99.9
± 0.00
Physical Activity Via Accelerometry (Bouts of Physical Activity)Secondary· Baseline
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.
Group
Value
95% CI
Brenner FIT (Standard Care)
60.75
± 54.63
Brenner mFIT (Standard Care Plus Mobile Health Components)
73.33
± 49.14
Physical Activity Via Accelerometry (Bouts of Physical Activity)Secondary· 6 months
Physical activity data will be collected using ActiGraph (trademark) accelerometers worn continuously over 7 days except during bathing and sleeping.
Group
Value
95% CI
Brenner FIT (Standard Care)
13.5
± 5.0
Brenner mFIT (Standard Care Plus Mobile Health Components)
To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day).
Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges.
Group
Value
95% CI
Brenner FIT (Standard Care)
2135.27
± 806.66
Brenner mFIT (Standard Care Plus Mobile Health Components)
To assess diet in participating youth, we will use NCI's automated, self-administered 24-hour dietary recall, the Automated Self-Administered 24-hour (ASA24 (registered trademark) dietary assessment tool (version: ASA24-2016) on three, non-consecutive days (including one weekend day).
Caloric intake will be expressed in kilocalories in order to compare dietary behavior following the delivery of some program components. There are no specific ranges.
Group
Value
95% CI
Brenner FIT (Standard Care)
1650.6
± 679.6
Economic Costs of the Two Intervention ArmsSecondary· Through study completion (6 months)
Clinical costs of the mHealth intervention will be compiled over the duration of the program. The number of participants reflects the number who remained in the program. Since the data refer to the costs of the participants' care and were not collected directly from the participants, the number of participants analyzed is not consistent with the other outcome measures. The intervention cost was calculated at the group level and not per participant.
Group
Value
95% CI
Brenner FIT (Standard Care)
2,616
Brenner mFIT (Standard Care Plus Mobile Health Components)
3,482
Economic Costs of the Two Intervention ArmsSecondary· Through study completion (6 months)
Clinical costs of the mHealth intervention will be compiled over the duration of the program. The number of participants reflects the number who remained in the program. Since the data refer to the costs of the participants' care and were not collected directly from the participants, the number of participants analyzed is not consistent with the other outcome measures. The intervention cost was calculated at the group level and not per participant.
Group
Value
95% CI
Brenner FIT (Standard Care)
2616
Brenner mFIT (Standard Care Plus Mobile Health Components)
3482
Economic Costs of the Two Intervention ArmsSecondary· Through study completion (6 months)
Clinical costs of the mHealth intervention will be compiled over the duration of the program. The number of participants reflects the number who remained in the program. Since the data refer to the costs of the participants' care and were not collected directly from the participants, the number of participants analyzed is not consistent with the other outcome measures. The intervention cost was calculated at the group level and not per participant.
Group
Value
95% CI
Brenner FIT (Standard Care)
2616
Brenner mFIT (Standard Care Plus Mobile Health Components)
3482
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06920862 — Multi-Modal Digital Interventions for Adolescent Weight Management
· NA
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 8 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03961061.