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| ID | Type | Description | Link |
|---|---|---|---|
| R03HD060137 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Weight Control with Enhanced Parent Involvement | Experimental | This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control. |
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| Behavioral Weight Control with Minimal Parent Involvement | Placebo Comparator | This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Weight Control with Enhanced Parent Involvement | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Post-treatment BMI (controlling for baseline BMI) | Baseline and at completion of 16 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Modeling 1: Dietary Choices (WCSS) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Mass Index | Post-treatment BMI (controlling for baseline BMI) | Posted | Mean | Standard Deviation | kilograms/meters squared | Baseline and at completion of 16 week intervention |
|
Baseline through post-treatment (4 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elissa Jelalian | Weight Control and Diabetes Research Center | (401) 793-9716 | elissa_jelalian@brown.edu |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| Behavioral Weight Control with Minimal Parent Involvement |
| Behavioral |
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| Baseline to post-treatment |
| Parent Modeling 2: Self-monitoring (WCSS) | 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. | Baseline to post-treatment |
| Parent Modeling 3: Physical Activity (WCSS) | 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. | Baseline to post-treatment |
| Parent Modeling 4: Weight and Body Concerns (FERF-Q) | 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. | Baseline to post-treatment |
| Communication 1: Negative Maternal Weight-related Commentary (FERF-Q) | 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. | Baseline to post-treatment |
| Communication 2: Observed Parent-adolescent Communication Quality (DOCS) | 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. | Baseline to post-treatment |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (kg/m^2) | Mean | Standard Deviation | kilograms/meters squared (kg/m2) |
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| Parent modeling 1: Dietary Choices (WCSS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Parent modeling 2: Self-monitoring (WCSS) | 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. | Mean | Standard Deviation | units on a scale |
|
| Parent modeling 3: Physical Activity (WCSS) | ). 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. | Mean | Standard Deviation | units on a scale |
|
| Parent modeling 4: Weight and Body Concerns | 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 greater scores corresponding to greater parent weight and body concerns, as perceived and reported by the adolescent. | Mean | Standard Deviation | units on a scale |
|
| Communication 1: Negative weight-related comments | 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. | Mean | Standard Deviation | units on a scale |
|
| Communication 2: Observed parent-adolescent communication quality | 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. | Mean | Standard Deviation | units on a scale |
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| Secondary | Parent Modeling 1: Dietary Choices (WCSS) | 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. | Secondary outcomes analyzed for treatment completers only. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
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| Secondary | Parent Modeling 2: Self-monitoring (WCSS) | 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. | Secondary outcomes analyzed for treatment completers only. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
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| Secondary | Parent Modeling 3: Physical Activity (WCSS) | 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. | Secondary outcomes analyzed for treatment completers only | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
|
|
|
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| Secondary | Parent Modeling 4: Weight and Body Concerns (FERF-Q) | 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. | Secondary outcomes analyzed for treatment completers only | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
|
|
|
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| Secondary | Communication 1: Negative Maternal Weight-related Commentary (FERF-Q) | 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. | Secondary outcomes analyzed for treatment completers only | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
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|
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| Secondary | Communication 2: Observed Parent-adolescent Communication Quality (DOCS) | 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. | 38 participants (19 in each group) had complete baseline and post treatment data for videotaped observations. | Posted | Mean | Standard Deviation | units on a scale | Baseline to post-treatment |
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| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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 | 0 | 23 | 0 | 23 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |