Trial Outcomes & Findings for The Role of Parents in Adolescent Weight Loss (NCT NCT01139411)
NCT ID: NCT01139411
Last Updated: 2016-09-30
Results Overview
Post-treatment BMI (controlling for baseline BMI)
COMPLETED
NA
49 participants
Baseline and at completion of 16 week intervention
2016-09-30
Participant Flow
Participant milestones
| Measure |
Behavioral Weight Control With Minimal Parent Involvement
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement
|
Behavioral Weight Control With Enhanced Parent Involvement
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
23
|
|
Overall Study
COMPLETED
|
24
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Parents in Adolescent Weight Loss
Baseline characteristics by cohort
| Measure |
Behavioral Weight Control With Enhanced Parent Involvement
n=23 Participants
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement
|
Behavioral Weight Control With Minimal Parent Involvement
n=26 Participants
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
15.21 years
STANDARD_DEVIATION 1.40 • n=5 Participants
|
15.00 years
STANDARD_DEVIATION 1.30 • n=7 Participants
|
15.10 years
STANDARD_DEVIATION 1.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
26 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Body Mass Index (kg/m^2)
|
33.25 kilograms/meters squared (kg/m2)
STANDARD_DEVIATION 4.02 • n=5 Participants
|
31.17 kilograms/meters squared (kg/m2)
STANDARD_DEVIATION 3.01 • n=7 Participants
|
32.16 kilograms/meters squared (kg/m2)
STANDARD_DEVIATION 3.64 • n=5 Participants
|
|
Parent modeling 1: Dietary Choices (WCSS)
|
2.70 units on a scale
STANDARD_DEVIATION 0.76 • n=5 Participants
|
2.32 units on a scale
STANDARD_DEVIATION 1.13 • n=7 Participants
|
2.50 units on a scale
STANDARD_DEVIATION 0.98 • n=5 Participants
|
|
Parent modeling 2: Self-monitoring (WCSS)
|
.81 units on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
0.55 units on a scale
STANDARD_DEVIATION 0.70 • n=7 Participants
|
0.67 units on a scale
STANDARD_DEVIATION 0.75 • n=5 Participants
|
|
Parent modeling 3: Physical Activity (WCSS)
|
1.75 units on a scale
STANDARD_DEVIATION 1.17 • n=5 Participants
|
0.90 units on a scale
STANDARD_DEVIATION 1.05 • n=7 Participants
|
1.30 units on a scale
STANDARD_DEVIATION 1.18 • n=5 Participants
|
|
Parent modeling 4: Weight and Body Concerns
|
2.75 units on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
2.90 units on a scale
STANDARD_DEVIATION 0.89 • n=7 Participants
|
2.83 units on a scale
STANDARD_DEVIATION 0.84 • n=5 Participants
|
|
Communication 1: Negative weight-related comments
|
2.73 units on a scale
STANDARD_DEVIATION 0.73 • n=5 Participants
|
2.85 units on a scale
STANDARD_DEVIATION 0.64 • n=7 Participants
|
2.79 units on a scale
STANDARD_DEVIATION 0.70 • n=5 Participants
|
|
Communication 2: Observed parent-adolescent communication quality
|
5.5 units on a scale
STANDARD_DEVIATION 2.1 • n=5 Participants
|
5.8 units on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and at completion of 16 week interventionPost-treatment BMI (controlling for baseline BMI)
Outcome measures
| Measure |
Behavioral Weight Control With Minimal Parent Involvement
n=26 Participants
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement
|
Behavioral Weight Control With Enhanced Parent Involvement
n=23 Participants
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement
|
|---|---|---|
|
Body Mass Index
|
29.89 kilograms/meters squared
Standard Deviation 3.41
|
32.82 kilograms/meters squared
Standard Deviation 4.06
|
SECONDARY outcome
Timeframe: Baseline to post-treatmentPopulation: Secondary outcomes analyzed for treatment completers only.
Post-treatment value (controlling for baseline). Parent modeling of dietary choices was assessed using the Diet Choices subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Dietary choices subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to healthier diet choices. Higher scores are considered to be a better treatment outcome.
Outcome measures
| Measure |
Behavioral Weight Control With Minimal Parent Involvement
n=19 Participants
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement
|
Behavioral Weight Control With Enhanced Parent Involvement
n=24 Participants
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement
|
|---|---|---|
|
Parent Modeling 1: Dietary Choices (WCSS)
|
2.92 units on a scale
Standard Deviation 0.82
|
2.87 units on a scale
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline to post-treatmentPopulation: Secondary outcomes analyzed for treatment completers only.
Post-treatment value (controlling for baseline). Parent modeling of self-monitoring behavior was assessed using the Self Monitoring subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Self Monitoring subscale of the WCSS has a scale range of 0 - 4, with higher scores corresponding to more self-monitoring behavior. Higher scores are thought to reflect a better treatment outcome.
Outcome measures
| Measure |
Behavioral Weight Control With Minimal Parent Involvement
n=24 Participants
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement
|
Behavioral Weight Control With Enhanced Parent Involvement
n=19 Participants
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement
|
|---|---|---|
|
Parent Modeling 2: Self-monitoring (WCSS)
|
0.81 units on a scale
Standard Deviation 0.81
|
1.28 units on a scale
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline to post-treatmentPopulation: Secondary outcomes analyzed for treatment completers only
Post-treatment value (controlling for baseline). Parent modeling of Physical Activity was assessed using the Physical Activity subscale of the Weight Control Strategies Scale (WCSS), a parent-report measure of his/her own healthy weight control practices. The Physical Activity subscale of the WCSS has a scale range of 0-4, with higher scores corresponding to greater physical activity. Higher scores are considered a better treatment outcome.
Outcome measures
| Measure |
Behavioral Weight Control With Minimal Parent Involvement
n=19 Participants
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement
|
Behavioral Weight Control With Enhanced Parent Involvement
n=24 Participants
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement
|
|---|---|---|
|
Parent Modeling 3: Physical Activity (WCSS)
|
1.9 units on a scale
Standard Deviation 1.0
|
1.32 units on a scale
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Baseline to post-treatmentPopulation: Secondary outcomes analyzed for treatment completers only
Post-treatment value (controlling for baseline). Parent modeling of concern about weight/body was assessed using the Parent Modeling of Weight and Body Concerns subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Weight and Body Concerns subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. Lower weight and body concern is considered a better treatment outcome.
Outcome measures
| Measure |
Behavioral Weight Control With Minimal Parent Involvement
n=19 Participants
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement
|
Behavioral Weight Control With Enhanced Parent Involvement
n=24 Participants
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement
|
|---|---|---|
|
Parent Modeling 4: Weight and Body Concerns (FERF-Q)
|
2.63 units on a scale
Standard Deviation 1.02
|
2.64 units on a scale
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Baseline to post-treatmentPopulation: Secondary outcomes analyzed for treatment completers only
Post-treatment value (controlling for baseline). Negative maternal weight-related commentary was assessed using the Negative maternal weight-related commentary subscale of the Family Experiences Related to Food Questionnaire (FERF-Q)), an adolescent-report measure of parent behavior pertaining to weight control. The Negative maternal weight-related commentary subscale of the FERF-Q has a scale range of 1 - 5, with higher scores corresponding to greater negative maternal weight-related commentary, as perceived and reported by the adolescent. Lower scores are considered a better treatment outcome.
Outcome measures
| Measure |
Behavioral Weight Control With Minimal Parent Involvement
n=19 Participants
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement
|
Behavioral Weight Control With Enhanced Parent Involvement
n=24 Participants
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement
|
|---|---|---|
|
Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)
|
2.71 units on a scale
Standard Deviation 0.80
|
2.32 units on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline to post-treatmentPopulation: 38 participants (19 in each group) had complete baseline and post treatment data for videotaped observations.
Post-treatment value (controlling for baseline). Observed parent-adolescent communication quality was measured using the Dyadic Observed Communication Scale (DOCS) used to code communication between adolescent and caregiver during a video-taped observational coding session. The DOCS is coded on a scale of 0 -10, with higher scores reflecting higher quality of communication, as observed by an independent rater. Higher scores are thought to reflect a better treatment outcome.
Outcome measures
| Measure |
Behavioral Weight Control With Minimal Parent Involvement
n=19 Participants
This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.
Behavioral Weight Control with Minimal Parent Involvement
|
Behavioral Weight Control With Enhanced Parent Involvement
n=19 Participants
This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.
Behavioral Weight Control with Enhanced Parent Involvement
|
|---|---|---|
|
Communication 2: Observed Parent-adolescent Communication Quality (DOCS)
|
5.5 units on a scale
Standard Deviation 1.9
|
5.8 units on a scale
Standard Deviation 1.8
|
Adverse Events
Behavioral Weight Control With Minimal Parent Involvement
Behavioral Weight Control With Enhanced Parent Involvement
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Elissa Jelalian
Weight Control and Diabetes Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place