The Role of Parents in Adolescent Weight Loss

• Sponsor: The Miriam Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01139411
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 49
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of the study is to determine whether a novel model of including parents in adolescent weight control results in greater decrease in adolescent z-BMI compared to an intervention with minimal parent involvement.

Condition or Disease	Intervention/Treatment	Phase
Adolescent Obesity	Behavioral: Behavioral Weight Control with Enhanced Parent Involvement; Behavioral: Behavioral Weight Control with Minimal Parent Involvement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Parental Involvement as a Strategy to Enhance Adolescent Weight Control
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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: Behavioral Weight Control with Enhanced Parent Involvement
Placebo Comparator: Behavioral Weight Control with Minimal Parent Involvement This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.	Behavioral: Behavioral Weight Control with Minimal Parent Involvement

Outcome Measures

Primary Outcome Measures

1. Body Mass Index [Baseline and at completion of 16 week intervention]

   Post-treatment BMI (controlling for baseline BMI)

Secondary Outcome Measures

1. Parent Modeling 1: Dietary Choices (WCSS) [Baseline to post-treatment]

   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.

2. Parent Modeling 2: Self-monitoring (WCSS) [Baseline to post-treatment]

   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.

3. Parent Modeling 3: Physical Activity (WCSS) [Baseline to post-treatment]

   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.

4. Parent Modeling 4: Weight and Body Concerns (FERF-Q) [Baseline to post-treatment]

   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.

5. Communication 1: Negative Maternal Weight-related Commentary (FERF-Q) [Baseline to post-treatment]

   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.

6. Communication 2: Observed Parent-adolescent Communication Quality (DOCS) [Baseline to post-treatment]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Between 30 and 90% overweight

• Parent or guardian willing to participate

Exclusion Criteria:

• Major psychiatric disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Miriam Hospital	Providence	Rhode Island	United States	02906

Sponsors and Collaborators

• The Miriam Hospital
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elissa Jelalian, Senior Scientist, The Miriam Hospital
• ClinicalTrials.gov Identifier: NCT01139411
• Other Study ID Numbers: GRANT00538804; R03HD060137
• First Posted: Jun 8, 2010
• Last Update Posted: Sep 30, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Pediatric Obesity

Study Results

Participant Flow

Arm/Group Title	Behavioral Weight Control With Minimal Parent Involvement	Behavioral Weight Control With Enhanced Parent Involvement
Arm/Group Description	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal 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
Period Title: Overall Study
STARTED	26	23
COMPLETED	24	19
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	Behavioral Weight Control With Enhanced Parent Involvement	Behavioral Weight Control With Minimal Parent Involvement	Total
Arm/Group Description	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	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal Parent Involvement	Total of all reporting groups
Overall Participants	23	26	49
Age (Count of Participants)
<=18 years	23 100%	26 100%	49 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.21 (1.40)	15.00 (1.30)	15.10 (1.33)
Sex: Female, Male (Count of Participants)
Female	20 87%	17 65.4%	37 75.5%
Male	3 13%	9 34.6%	12 24.5%
Region of Enrollment (participants) [Number]
United States	23 100%	26 100%	49 100%
Body Mass Index (kg/m^2) (kilograms/meters squared (kg/m2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms/meters squared (kg/m2)]	33.25 (4.02)	31.17 (3.01)	32.16 (3.64)
Parent modeling 1: Dietary Choices (WCSS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.70 (0.76)	2.32 (1.13)	2.50 (0.98)
Parent modeling 2: Self-monitoring (WCSS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	.81 (0.80)	0.55 (0.70)	0.67 (0.75)
Parent modeling 3: Physical Activity (WCSS) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.75 (1.17)	0.90 (1.05)	1.30 (1.18)
Parent modeling 4: Weight and Body Concerns (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.75 (0.80)	2.90 (0.89)	2.83 (0.84)
Communication 1: Negative weight-related comments (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.73 (0.73)	2.85 (0.64)	2.79 (0.70)
Communication 2: Observed parent-adolescent communication quality (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.5 (2.1)	5.8 (1.9)	5.7 (1.9)

Outcome Measures

1. Primary Outcome

Title	Body Mass Index
Description	Post-treatment BMI (controlling for baseline BMI)
Time Frame	Baseline and at completion of 16 week intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Behavioral Weight Control With Minimal Parent Involvement	Behavioral Weight Control With Enhanced Parent Involvement
Arm/Group Description	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal 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
Measure Participants	26	23
Mean (Standard Deviation) [kilograms/meters squared]	29.89 (3.41)	32.82 (4.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Weight Control With Minimal Parent Involvement, Behavioral Weight Control With Enhanced Parent Involvement
	Comments	Null hypothesis was that the amount of weight lost by adolescents in Enhanced Parent Involvement and Minimal Parent involvement would not be significantly different. The study was powered at .8 to achieve a medium effect size (f = .26; partial eta sq. = 0.06). The end-of-treatment BMI value was the dependent variable, with the baseline BMI value entered as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments	Threshold for significance: 0.05
	Method	ANCOVA
	Comments

2. Secondary Outcome

Title	Parent Modeling 1: Dietary Choices (WCSS)
Description	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.
Time Frame	Baseline to post-treatment

Outcome Measure Data

Analysis Population Description

Secondary outcomes analyzed for treatment completers only.

Arm/Group Title	Behavioral Weight Control With Enhanced Parent Involvement	Behavioral Weight Control With Minimal Parent Involvement
Arm/Group Description	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	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal Parent Involvement
Measure Participants	19	24
Mean (Standard Deviation) [units on a scale]	2.92 (0.82)	2.87 (0.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Weight Control With Minimal Parent Involvement, Behavioral Weight Control With Enhanced Parent Involvement
	Comments	The end-of-treatment value was the dependent variable, with the baseline value entered as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.58
	Comments	Threshold for significance: 0.05
	Method	ANCOVA
	Comments

3. Secondary Outcome

Title	Parent Modeling 2: Self-monitoring (WCSS)
Description	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.
Time Frame	Baseline to post-treatment

Outcome Measure Data

Analysis Population Description

Secondary outcomes analyzed for treatment completers only.

Arm/Group Title	Behavioral Weight Control With Minimal Parent Involvement	Behavioral Weight Control With Enhanced Parent Involvement
Arm/Group Description	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal 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
Measure Participants	24	19
Mean (Standard Deviation) [units on a scale]	0.81 (0.81)	1.28 (0.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Weight Control With Minimal Parent Involvement, Behavioral Weight Control With Enhanced Parent Involvement
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments	Threshold for significance: 0.05
	Method	ANCOVA
	Comments

4. Secondary Outcome

Title	Parent Modeling 3: Physical Activity (WCSS)
Description	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.
Time Frame	Baseline to post-treatment

Outcome Measure Data

Analysis Population Description

Secondary outcomes analyzed for treatment completers only

Arm/Group Title	Behavioral Weight Control With Enhanced Parent Involvement	Behavioral Weight Control With Minimal Parent Involvement
Arm/Group Description	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	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal Parent Involvement
Measure Participants	19	24
Mean (Standard Deviation) [units on a scale]	1.9 (1.0)	1.32 (0.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Weight Control With Minimal Parent Involvement, Behavioral Weight Control With Enhanced Parent Involvement
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.72
	Comments	Threshold for significance: 0.05
	Method	ANCOVA
	Comments

5. Secondary Outcome

Title	Parent Modeling 4: Weight and Body Concerns (FERF-Q)
Description	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.
Time Frame	Baseline to post-treatment

Outcome Measure Data

Analysis Population Description

Secondary outcomes analyzed for treatment completers only

Arm/Group Title	Behavioral Weight Control With Enhanced Parent Involvement	Behavioral Weight Control With Minimal Parent Involvement
Arm/Group Description	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	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal Parent Involvement
Measure Participants	19	24
Mean (Standard Deviation) [units on a scale]	2.63 (1.02)	2.64 (0.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Weight Control With Minimal Parent Involvement, Behavioral Weight Control With Enhanced Parent Involvement
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments
	Method	ANCOVA
	Comments

6. Secondary Outcome

Title	Communication 1: Negative Maternal Weight-related Commentary (FERF-Q)
Description	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.
Time Frame	Baseline to post-treatment

Outcome Measure Data

Analysis Population Description

Secondary outcomes analyzed for treatment completers only

Arm/Group Title	Behavioral Weight Control With Enhanced Parent Involvement	Behavioral Weight Control With Minimal Parent Involvement
Arm/Group Description	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	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal Parent Involvement
Measure Participants	19	24
Mean (Standard Deviation) [units on a scale]	2.71 (0.80)	2.32 (0.70)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Weight Control With Minimal Parent Involvement, Behavioral Weight Control With Enhanced Parent Involvement
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	Threshold for significance: 0.05
	Method	ANCOVA
	Comments

7. Secondary Outcome

Title	Communication 2: Observed Parent-adolescent Communication Quality (DOCS)
Description	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.
Time Frame	Baseline to post-treatment

Outcome Measure Data

Analysis Population Description

38 participants (19 in each group) had complete baseline and post treatment data for videotaped observations.

Arm/Group Title	Behavioral Weight Control With Enhanced Parent Involvement	Behavioral Weight Control With Minimal Parent Involvement
Arm/Group Description	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	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal Parent Involvement
Measure Participants	19	19
Mean (Standard Deviation) [units on a scale]	5.5 (1.9)	5.8 (1.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Behavioral Weight Control With Minimal Parent Involvement, Behavioral Weight Control With Enhanced Parent Involvement
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.61
	Comments	Threshold for significance: 0.05
	Method	ANCOVA
	Comments

Adverse Events

Time Frame	Baseline through post-treatment (4 months)
Arm/Group Title	Behavioral Weight Control With Minimal Parent Involvement		Behavioral Weight Control With Enhanced Parent Involvement
Arm/Group Description	This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. Behavioral Weight Control with Minimal 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
All Cause Mortality
	Behavioral Weight Control With Minimal Parent Involvement		Behavioral Weight Control With Enhanced Parent Involvement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Behavioral Weight Control With Minimal Parent Involvement		Behavioral Weight Control With Enhanced Parent Involvement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Behavioral Weight Control With Minimal Parent Involvement		Behavioral Weight Control With Enhanced Parent Involvement
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/23 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.