Last reviewed · How we verify

NCT03304249

Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

Completed NA Results posted Last updated 13 September 2023
What this trial tests

NA trial testing iAmHealthy Healthy Lifestyles Program in Weight Loss in 296 participants. Completed in 20 June 2022.

Timeline
13 October 2017
Primary endpoint
30 November 2021
20 June 2022

Quick facts

Lead sponsorUniversity of Kansas Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment296
Start date13 October 2017
Primary completion30 November 2021
Estimated completion20 June 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Kansas Medical Center

Who can join

Adults 5 to 10, any sex, with Weight Loss. 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.

Child Body Mass Index Z-score (BMIz) at Baseline and Month 8 Primary · Baseline to Month 8

Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = \[(BMI/M)\^L - 1\] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.

Baseline
GroupValue95% CI
iAmHealthy1.78± 0.54
Control1.92± 0.47
Month 8
GroupValue95% CI
iAmHealthy1.78± 0.54
Control1.96± 0.48
Child Body Mass Index Z-score (BMIz) at Baseline and Month 20 Secondary · Baseline to Month 20

Body mass index z-score (BMIz) is the age and sex standardized body mass index for children. To calculate BMIz, the equation BMIz = \[(BMI/M)\^L - 1\] ÷ (L × S) is used where M is the median, L is the power transformation to achieve normality, and S is the coefficient of variation. A z-score of 0 represents the historical population norm. A higher BMIz is indicative of higher fat mass.

Baseline
GroupValue95% CI
iAmHealthy1.78± 0.54
Control1.92± 0.47
Month 20
GroupValue95% CI
iAmHealthy1.82± 0.50
Control2.04± 0.46
Physical Activity - Average Minutes of Moderate to Vigorous Physical Activity Per Day Secondary · Baseline, Month 8, Month 20

Measured using ActiGraph physical activity monitors. Outcome will be calculated as the average (across valid wear days) time spent per day in moderate to vigorous physical activity (MVPA).

Baseline
GroupValue95% CI
iAmHealthy51.14± 22.72
Control52.95± 18.99
Month 8
GroupValue95% CI
iAmHealthy47.16± 18.82
Control49.07± 22.49
Month 20
GroupValue95% CI
iAmHealthy44.86± 18.81
Control41.37± 18.57
Physical Activity - % Time in Sedentary Activity Secondary · Baseline, Month 8, Month 20

Measured using ActiGraph physical activity monitors. Outcome was calculated as the percentage of time time spent in sedentary activity compared to wear time.

Baseline
GroupValue95% CI
iAmHealthy59.14± 7.12
Control56.57± 6.60
Month 8
GroupValue95% CI
iAmHealthy61.14± 8.55
Control59.62± 9.00
Month 20
GroupValue95% CI
iAmHealthy63.89± 8.09
Control63.28± 8.11
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Fruits and Vegetables Secondary · Baseline, Month 8, Month 20

The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.

Baseline
GroupValue95% CI
iAmHealthy3.27± 1.66
Control2.68± 1.38
Month 8
GroupValue95% CI
iAmHealthy3.04± 1.68
Control2.45± 1.41
Month 20
GroupValue95% CI
iAmHealthy2.89± 1.58
Control2.58± 1.16
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of Sugar-sweetened Beverages Secondary · Baseline, Month 8, Month 20

The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance/

Baseline
GroupValue95% CI
iAmHealthy1.19± 0.89
Control1.14± 0.99
Month 8
GroupValue95% CI
iAmHealthy0.75± 0.66
Control1.08± 0.89
Month 20
GroupValue95% CI
iAmHealthy0.93± 0.84
Control1.21± 1.06
Photo-assisted 24 Hour Food Recall (24hr FR) - Servings of "Red Foods" (Foods High in Sugar and/or Fat) Secondary · Baseline, Month 8, Month 20

The photo assisted 24hr FR is a standardized five-pass method, developed by the US Department of Agriculture for use in national dietary surveillance.

Baseline
GroupValue95% CI
iAmHealthy6.64± 2.43
Control7.40± 3.91
Month 8
GroupValue95% CI
iAmHealthy5.12± 1.89
Control6.28± 2.28
Month 20
GroupValue95% CI
iAmHealthy5.69± 2.00
Control6.89± 2.31
Parent Body Mass Index (BMI) Secondary · Baseline, Month 8, Month 20

Parent BMI was calculated at three time points.

Baseline
GroupValue95% CI
iAmHealthy35.83± 9.14
Control33.69± 8.81
Month 8
GroupValue95% CI
iAmHealthy35.94± 9.73
Control33.79± 9.32
Month 20
GroupValue95% CI
iAmHealthy35.23± 9.03
Control34.31± 9.53

Sponsor's own description

The purpose of this study is to learn if providing a family-based group program using mobile health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child weight, nutrition, and physical activity.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Conducting a pediatric randomized clinical trial during a pandemic: A shift to virtual procedures.
    Roberts JR, Chervinskiy SK, McCulloh R, Snowden J, et al · · 2022 · cited 15× · PMID 36285019 · DOI 10.1017/cts.2022.453
  2. Validation of remote height and weight assessment in a rural randomized clinical trial.
    Forseth B, Davis AM, Bakula DM, Murray M, et al · · 2022 · cited 12× · PMID 35818033 · DOI 10.1186/s12874-022-01669-8
  3. Effectiveness of a paediatric weight management intervention for rural youth (iAmHealthy): Primary outcomes of a cluster randomised control trial.
    Davis A, Lancaster B, Fleming K, Swinburne Romine R, et al · · 2024 · cited 8× · PMID 38173133 · DOI 10.1111/ijpo.13094
  4. Barriers to Participation in a Telemedicine-based, Family-based Behavioral Group Treatment Program for Pediatric Obesity: Qualitative findings from Rural Caregivers.
    Hoft G, Forseth B, Trofimoff A, Bangash M, et al · · 2024 · cited 4× · PMID 38239336 · DOI 10.1080/02739615.2023.2189116
  5. The impact of COVID-19 on rural treatment-seeking families with children with overweight or obesity.
    Forseth B, Dean KM, Murray M, Killian HJ, et al · · 2022 · cited 3× · PMID 36212032 · DOI 10.1080/02739615.2022.2041419
  6. Mental health outcomes of a pediatric-focused obesity randomized control trial in rural communities.
    Lancaster B, Goldenberg E, Trofimoff AS, Dai Y, et al · · 2025 · PMID 40440117 · DOI 10.1037/hea0001518
  7. The Impact of the COVID-19 Pandemic on Healthy Lifestyles in Rural Families.
    England KM, Forseth B, Bangash M, Bhagat R, et al · · 2022 · PMID 36199811 · DOI 10.51250/jheal.v2i1.30

Verify or expand the search:

Other recruiting trials for Weight Loss

Currently open trials in the same condition.

Other University of Kansas Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03304249.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing