- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03851796
Parent Involvement in Adolescent Obesity Treatment (TEENS+)
The Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Investigators will recruit adolescents with overweight or obesity (BMI>85th percentile) and a parent (BMI > 25 kg/m2). Families will participate in one of two 4-month treatments: 1) TEENS+ Parents as Coaches (PAC), engaging parents as helpers in their child's weight management, or 2) TEENS+ Parent Weight Loss (PWL), engaging parents in their own weight management. All adolescents will participate in TEENS+, which includes behavioral support, nutrition education, and supervised physical activity.
For adolescents, the intervention will consist of weekly behavioral weight management group sessions and weekly 1 hour exercise sessions. Each adolescent also has a monthly individual session with a behavior coach. Parent groups meet weekly for 1 hour according to treatment arm (PAC or PWL). All PWL sessions are separate from their adolescent. Bi-weekly sessions in the PAC arm are combined with parents and adolescent. Assessments will consist of anthropometric measures, psychological surveys and dietary and PA evaluations. Assessments will be completed at baseline, 2 months, 4 months (post-test), 8 months and 1 year.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Henrico, Virginia, United States, 23239
- Children's Hospital of Richmond at VCU Healthy Lifestyles Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: TEENS+Parents as Coaches
Parents are taught strategies to support and facilitate child weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on strategies to facilitate healthy weight management in their child(ren). Topics include role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen. They receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents will receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program. |
Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment.
Other Names:
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Active Comparator: TEENS+Parent Weight Loss
Parents are given a weight loss goal of 1-2 lbs/week, and specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program. All adolescents participate in a group-based empirically supported behavioral weight management treatment, that includes dietary and physical activity goals, and instructions to self-monitor key information. Adolescents receive training in core behavioral weight loss strategies (e.g. goal setting, stimulus control) and techniques to help them achieve these goals. They also receive personalized feedback throughout the program. |
Parent Weight loss teaches core behavioral weight loss strategies and techniques for parent weight loss; adolescents are in a group based behavioral weight management treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Body Mass Index (BMI) Change
Time Frame: 4 months to 12 month [follow up phase]
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Body Mass Index (BMI) change (kg/m2; adolescent) during the maintenance phase (4-month to 12-month).
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4 months to 12 month [follow up phase]
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Body Mass Index
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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National Health and Nutrition Examination Survey (NHANES) Anthropometry methods were used to measure height and weight to calculate Body Mass Index (BMI).
At 0, 2, 4, 8, 12 months, trained staff measured adolescent height and weight (in light clothing and after a 12 hour fast) to the nearest 0.1cm and 0.1kg using a precision stadiometer and digital scale, respectively.
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Baseline, 2-, 4-, 8-, and 12-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent Weight
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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Trained staff will measure weight (in light clothing and after a 12 hour fast) to the nearest 0.1kg using digital scale at baseline, 2-, 4-, 8- and 12-months.
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Baseline, 2-, 4-, 8-, and 12-months
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Parent Weight Change
Time Frame: baseline to 4 month [intervention phase] and 4 month to 12 month [maintenance phase]
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Trained staff will measure weight (in light clothing and after a 12 hour fast) to the nearest 0.1kg using digital scale at baseline and 4-months.
Weight change will be calculated from these values.
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baseline to 4 month [intervention phase] and 4 month to 12 month [maintenance phase]
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Physical Activity
Time Frame: Baseline, 4-, 8-, and 12-months
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Accelerometers were worn for 1 week by adolescents and parents for each assessment period (0, 4, 8, and 12 months) to assess adolescent and parent physical activity.
Results represent total time (minutes/day) spent in moderate/vigorous activity (MVPA).
Data reported is based off the average MVPA minutes per day of valid wear days.
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Baseline, 4-, 8-, and 12-months
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Physical Activity Change
Time Frame: 4-month to 12-month
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To assess adolescent and parent physical activity change during the maintenance physical (post-intervention) phase of the program from 4-months to 12-months.
Results represent the change in total time (minutes/day) spent in moderate/vigorous activity (MVPA).
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4-month to 12-month
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Physical Activity Energy Expenditure
Time Frame: Baseline, 4-, 8-, and 12-months
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Accelerometers will be worn for 1 week by adolescents and parents for each assessment period (0, 4, 8, and 12 months) to assess adolescent and parent physical activity energy expenditure (EE).
Results represent the average daily physical activity energy expenditure (kilocalories/day) estimated via accelerometer.
Results are based off EE = (Metabolic Equivalent of Task [MET] value of activity x body weight kg x [minutes of activity/60]) with MET values of 2.5, 4, and 7 utilized for light, moderate, and vigorous activities, respectively.
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Baseline, 4-, 8-, and 12-months
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Physical Activity Energy Expenditure Change
Time Frame: 4-month to 12-month
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To assess adolescent and parent physical activity energy expenditure change during the maintenance physical (post-intervention) phase of the program from 4-months to 12-months.
Results represent the change in total kilocalories per day from physical activity.
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4-month to 12-month
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Dietary Intake
Time Frame: Baseline, 4-, 8-, and 12-months
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Adolescent and parent participants completed a 3-day food record to track dietary intake for 2 weekdays and 1 weekend day in the week prior to their assessment (0, 4, 8, 12m).
Recall data was entered the Nutrition Data System for Research Software (NDSR) by trained staff.
Parent and adolescent average total energy intake (kilocalories/day) from the logged days is reported.
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Baseline, 4-, 8-, and 12-months
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Home Food Environment
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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The Home Food Inventory (HFI) was used to assess the availability of types of food in the home and calculate an overall obesogenic score.
Scores range from 0-60, with high scores indicating a more obesogenic food environment.
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Baseline, 2-, 4-, 8-, and 12-months
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Parent Reported Parenting Style
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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The Parenting Styles and Dimension Questionnaire (PSDQ) was administered to parents to assess parent self-report of authoritative parenting style.
Results reflect the participating parent's perception of their parenting style.
Scores range from 1-5 with higher scoring indicating a greater frequency of authoritative parenting behaviors.
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Baseline, 2-, 4-, 8-, and 12-months
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Role Modeling
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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At 0, 2, 4, 8, 12 months, adolescents will complete the Family Experiences Related to Food Questionnaire (FERFQ) is an 8 or 9-item measure (father and mother version, respectively) that will assess family commentary about weight and shape as well as family modeling of diet and weight concerns.
Scores range from 1-5 with higher scores indicating more negative role modeling of dietary behaviors.
Results reflect the adolescent's perception on their parent (mom or dad) participating in the study.
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Baseline, 2-, 4-, 8-, and 12-months
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Restrictive Child Feeding Practices
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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Parents will complete the Child Feeding Questionnaire (CFQ; Adolescent version) to assess restrictive feeding style.
Scores range from 1-5 with higher scores indicating a greater degree of restrictive feeding practices.
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Baseline, 2-, 4-, 8-, and 12-months
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Overall Weight Control Practices
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) which will assess the use of healthy weight control practices (e.g., dietary choices, self-monitoring, and physical activity) at 0, 2, 4, 8, 12 months.
A total of 30 items are included in the measure, rated from 0-4.
Total scores (ranging from 0-4) are calculated by averaging the scores of the 30 items.
Higher scores indicate greater engagement in weight management behaviors.
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Baseline, 2-, 4-, 8-, and 12-months
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Self Monitoring Weight Control Practices
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) self-monitoring subscale which will assess the use of self-monitoring weight control practices at 0, 2, 4, 8, 12 months.
A total of 7 items are included in the measure, rated from 0-4.
Scores are calculated by averaging the scores of the 7 items.
Higher scores indicate greater engagement in self-monitoring weight management behaviors.
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Baseline, 2-, 4-, 8-, and 12-months
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Dietary Choices Weight Control Practices
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) dietary choices subscale which will assess the use of dietary choice weight control practices at 0, 2, 4, 8, 12 months.
A total of 10 items are included in the measure, rated from 0-4.
Scores range from 0 to 4 and are calculated by averaging the scores of the 10 items.
Higher scores indicate greater engagement in dietary choice weight management behaviors.
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Baseline, 2-, 4-, 8-, and 12-months
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Physical Activity Weight Control Practices
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) physical activity subscale which will assess the use of physical activity weight control practices at 0, 2, 4, 8, 12 months.
A total of 6 items are included in the measure, rated from 0-4.
Scores range from 0 to 4 and are calculated by averaging the scores of the 6 items.
Higher scores indicate greater engagement in physical activity weight management behaviors.
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Baseline, 2-, 4-, 8-, and 12-months
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Psychological Coping Weight Control Practices
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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Adolescents and parents will complete the Weight Control Strategies Scale (WCSS) psychological coping subscale which will assess the use of psychological coping weight control practices at 0, 2, 4, 8, 12 months.
A total of 7 items are included in the measure, rated from 0-4.
Scores range from 0 to 4 and are calculated by averaging the scores of the 7 items.
Higher scores indicate greater engagement in psychological coping weight management behaviors.
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Baseline, 2-, 4-, 8-, and 12-months
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Adolescent Reported Responsiveness Parenting Style
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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The Authoritative Parenting Index (API) was used to assess adolescent-report of responsiveness parenting style and will be administered at 0, 2, 4, 8, 12 months.
Scores range from 9-36 with higher scores indicating greater perceived responsiveness from the parent.
Results reflect the adolescent's perception on the parent (mom or dad) participating in the study.
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Baseline, 2-, 4-, 8-, and 12-months
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Adolescent Reported Demandingness Parenting Style
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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The Authoritative Parenting Index (API) was used to assess adolescent-report of demandingness parenting style and will be administered at 0, 2, 4, 8, 12 months.
Scores range from 7-28 with higher scores indicating greater perceived demandingness from the parent.
Results reflect the adolescent's perception on their parent (mom or dad) participating in the study.
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Baseline, 2-, 4-, 8-, and 12-months
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Adolescent Reported Authoritative Parenting Style
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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The Authoritative Parenting Index (API) was used to assess adolescent-report of authoritative parenting style and was administered at 0, 2, 4, 8, 12 months.
Scores range from 16-64 with higher scores indicating the adolescent perceives their parent to have a higher level of authoritative parenting behavior.
Results reflect the adolescent's perception on their parent (mom or dad) participating in the study.
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Baseline, 2-, 4-, 8-, and 12-months
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Home Exercise Environment
Time Frame: Baseline, 4-, 8-, and 12-months
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The Exercise Environment Questionnaire (EEQ) assessed the availability of types exercise equipment in the home.
Measures will be completed at 0, 4, 8, 12 months.
Scores are calculated by summing responses.
Scores range from 0-39 with higher scores indicating more exercise equipment in the home.
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Baseline, 4-, 8-, and 12-months
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Monitoring Child Feeding Practices
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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Parents will complete the Child Feeding Questionnaire (CFQ; Adolescent version) to assess monitoring feeding style.
Scores range from 1-5 with higher scores indicating a greater degree of monitoring feeding practices.
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Baseline, 2-, 4-, 8-, and 12-months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Autonomy Support
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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At 0, 2, 4, 8, 12 months, adolescents will complete the Perceived Parental Autonomy Support Scale (P-PASS) to assess adolescent perception of 1) autonomy-supportive parenting behaviors and 2) controlling parenting behaviors.
Items are rated on a 7-point Likert scale from 1-7.
The average score across all items is calculated.
Higher scores indicate a greater perception of parental autonomy support.
Lower scores indicate less support and more controlling behaviors.
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Baseline, 2-, 4-, 8-, and 12-months
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Parent Child Relationship
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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The Conflict Behavior Questionnaire (CBQ; Parent and Adolescent Versions) will assess parent and adolescent report of parent-child relational factors at 0, 2, 4, 8, 12 mo.
Scores range from 0-20.
Higher score indicate more conflict between parent and child and lower scores indicating less conflict.
Results reflect the adolescent's perception on their parent (mom or dad) participating in the study.
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Baseline, 2-, 4-, 8-, and 12-months
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Parent Self-efficacy
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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The Parent Efficacy for Child Healthy Weight Behavior (PECHWB) will assess parent self-efficacy in promoting healthy weight behaviors in their adolescents.
Scores range from 0-100 with higher scores indicating higher self-efficacy.
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Baseline, 2-, 4-, 8-, and 12-months
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Social Support
Time Frame: Baseline, 2-, 4-, 8-, and 12-months
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At 0, 2, 4, 8, 12 months, adolescents will complete family and friend social support scales from the Patient-based Assessment and Counseling for Physical Activity and Nutrition (PACE+) questionnaires to assess adolescent report of family and friend social support across 3 domains: 1) fruit and vegetable intake, 2) fat intake, and 3) physical activity.
Scores range from 1-5 with higher indicating greater social support.
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Baseline, 2-, 4-, 8-, and 12-months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Melanie K Bean, PhD, Virginia Commonwealth University
Publications and helpful links
General Publications
- Brown KL, LaRose JG, Raynor HA, Gorin AA, Thornton LM, Farthing S, Tatum K, Bean MK. Study design and rationale for TEENS+REACH: Evaluating ripple effects of a family-based lifestyle intervention to untreated family members. Contemp Clin Trials Commun. 2024 Feb 15;38:101276. doi: 10.1016/j.conctc.2024.101276. eCollection 2024 Apr.
- Bean MK, LaRose JG, Wickham EP 3rd, Raynor HA, Caccavale L, Evans RK, Thornton LM, Farthing S, Mendoza A, Mazzeo SE. The role of parents in behavioral treatment for adolescent obesity: design and rationale for the TEENS+ randomized clinical trial. BMC Public Health. 2023 Aug 4;23(1):1484. doi: 10.1186/s12889-023-16421-0.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20014304
- R01HD095910-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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