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N/A N=418 Randomized Double-blind Treatment

Parent Involvement in Adolescent Obesity Treatment

Pediatric Obesity

Enrolled (actual)
418
Serious AEs
2.6%
Results posted
Dec 2025
Primary outcome: Primary: Body Mass Index (BMI) Change — 1.51; 0.91 kg/m^2

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
TEENS+Parents as Coaches (Behavioral); TEENS+Parent Weight Loss (Behavioral)
Age
Pediatric · 12+ yrs
Sex
All
Sponsor
Virginia Commonwealth University
Primary completion
Oct 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Body Mass Index (BMI) Change
1.51; 0.91
PRIMARY
Body Mass Index
34.27; 34.71; 33.58; 34.16; 33.21; 33.92
SECONDARY
Parent Weight
99.18; 100.62; 97.39; 98.51; 98.50; 96.06
SECONDARY
Parent Weight Change
-1.20; -3.47; -0.32; 0.49
SECONDARY
Physical Activity
11.99; 11.92; 21.05; 22.51; 12.03; 12.41
SECONDARY
Physical Activity Change
-3.21; 3.24; -1.28; -3.68
SECONDARY
Physical Activity Energy Expenditure
915.73; 897.27; 1486.38; 1506.10; 815.05; 856.47
SECONDARY
Physical Activity Energy Expenditure Change
10.30; 67.74; 9.57; -36.39
SECONDARY
Dietary Intake
1830; 1807; 1699; 1817; 1539; 1502
SECONDARY
Home Food Environment
22.16; 22.28; 15.89; 18.54; 15.97; 17.09
SECONDARY
Parent Reported Parenting Style
4.08; 4.12; 4.07; 4.10; 4.12; 4.15
SECONDARY
Role Modeling
2.54; 2.57; 2.46; 2.52; 2.33; 2.46
SECONDARY
Restrictive Child Feeding Practices
3.54; 3.64; 3.36; 3.34; 3.17; 3.23
SECONDARY
Overall Weight Control Practices
1.23; 1.12; 1.35; 1.22; 2.25; 2.22
SECONDARY
Self Monitoring Weight Control Practices
0.61; 0.52; 0.76; 0.53; 2.29; 2.25
SECONDARY
Dietary Choices Weight Control Practices
1.90; 1.84; 2.22; 2.27; 2.65; 2.65
SECONDARY
Physical Activity Weight Control Practices
1.09; 0.91; 1.13; 0.86; 1.95; 1.88
SECONDARY
Psychological Coping Weight Control Practices
1.31; 1.21; 1.28; 1.20; 2.12; 2.09
SECONDARY
Adolescent Reported Responsiveness Parenting Style
27.59; 28.09; 28.00; 28.84; 28.84; 29.12
SECONDARY
Adolescent Reported Demandingness Parenting Style
21.78; 21.59; 22.11; 21.87; 22.31; 21.75
SECONDARY
Adolescent Reported Authoritative Parenting Style
49.37; 49.68; 50.11; 50.70; 51.15; 50.87
SECONDARY
Home Exercise Environment
11.51; 11.11; 13.66; 12.74; 13.02; 12.23
SECONDARY
Monitoring Child Feeding Practices
3.30; 3.21; 3.77; 3.41; 3.55; 3.25

Summary

A randomized control trial to compare the efficacy of two distinct parent treatments on weight loss maintenance for adolescents with obesity participating in a lifestyle intervention including nutrition education, exercise and behavioral support. Funding support from NIH via 1R01HD095910

Eligibility Criteria

Inclusion Criteria

Adolescent Inclusion Criteria:

  • BMI ≥ 85th percentile for age and gender according to the CDC Growth Charts
  • Age 12 to 16
  • Must reside with the primary participating parent

Parent Inclusion Criteria:

  • ≥18
  • BMI ≥ 25 kg/m2
  • Must reside with the adolescent

Exclusion Criteria

Adolescent Exclusion Criteria:

  • Non-English speaking
  • Medical condition(s) that may be associated with unintentional weight change
  • Diabetes mellitus
  • Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation
  • Use of a GLP-1 within 6 months of study participation
  • Use of Depo-Provera within 6 months of study participation
  • Medical condition(s) that may be negatively impacted by exercise
  • Psychiatric, cognitive, physical or developmental conditions that would impair the ability to complete assessments, participate in a group, or conduct physical activity
  • Reports of compensatory behaviors in the past 3 months
  • Current pregnancy or plan to become pregnant during study period
  • Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304
  • Current participation in another weight loss program
  • Personal history of weight loss surgery
  • Severe depression
  • Clinically significant eating disorder
  • Change in dose of metformin, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation
  • Admission to a psychiatric hospital within the past year

Parent Exclusion Criteria:

  • Non-English speaking
  • Medical condition(s) that may be associated with unintentional weight change
  • Use of oral glucocorticoids, atypical antipsychotics, weight loss medications, or an investigational medication within 3 months of study participation
  • Use of a GLP-1 within 6 months of study participation with no T2D diagnosis; if T2D diagnosis, change in dose GLP-1 within 3 months of study participation
  • Use of Depo-Provera within 6 months of study participation
  • Psychiatric, cognitive, physical or developmental conditions that would impair the ability to complete assessments, participate in a group, or conduct physical activity
  • Reports of compensatory behaviors in the past 3 months
  • Current pregnancy, lactation, less than 6 months post-partum, or plan to become pregnant during study period
  • Previous participation in HM20010365, HM20003076, HM20005235 or HM20014304
  • Current participation in another weight loss program
  • Personal history of weight loss surgery
  • Severe depression
  • Clinically significant eating disorder
  • Change in dose of diabetes medications, tricyclic antidepressants, selective serotonin uptake inhibitors, or stimulant medications within 3 months of study participation
  • Admission to a psychiatric hospital within the past year
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03851796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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