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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD095910-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of North Carolina | OTHER |
| University of Tennessee | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEENS+Parents as Coaches | Active Comparator | 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. |
|
| TEENS+Parent Weight Loss | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEENS+Parents as Coaches | Behavioral | Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) Change | Body Mass Index (BMI) change (kg/m2; adolescent) during the maintenance phase (4-month to 12-month). | 4 months to 12 month [follow up phase] |
| Body Mass Index | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Weight | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Parent Weight Change |
| Measure | Description | Time Frame |
|---|---|---|
| Autonomy Support | 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. |
Inclusion Criteria:
Adolescent Inclusion Criteria:
Parent Inclusion Criteria:
Exclusion Criteria:
Adolescent Exclusion Criteria:
Parent Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melanie K Bean, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Richmond at VCU Healthy Lifestyles Center | Henrico | Virginia | 23239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38404649 | Derived | 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. | |
| 37537548 | Derived | 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. |
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Recruitment for the trial occurred from March 2019 through August 2023 with more strategized recruitment methods occurring 3-4 months prior to the start of each cohort. We implemented a comprehensive recruitment plan which included: establishing relationships with community practices for provider referrals; physician-endorsed letters; direct mail; social media and targeted digital ads; local newspaper/magazine/radio ads; flyers/posters in medical offices/hospital; listservs; community events.
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| ID | Title | Description |
|---|---|---|
| FG000 | Teens with parents in PAC | 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 receive personalized feedback throughout the program. These adolescents have a participating parent in the Parents as Coaches (PAC) treatment arm. |
| FG001 | Teens with parents in PWL | 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 receive personalized feedback throughout the program. These adolescents have a participating parent in the Parent Weight Loss (PWL) treatment arm. |
| FG002 | Parents as Coaches (PAC) | 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. |
| FG003 | Parent Weight Loss (PWL) | 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 receive personalized feedback throughout the program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Teens With Parents in PAC | 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 receive personalized feedback throughout the program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 (BMI) Change | Body Mass Index (BMI) change (kg/m2; adolescent) during the maintenance phase (4-month to 12-month). | Data presented includes the participants who completed body weight measurements at the respective time points [4 & 12m] and the change in BMI between the two time points. | Posted | Mean | Standard Deviation | kg/m^2 | 4 months to 12 month [follow up phase] |
|
4-, 8-, and 12-months
Adverse event information was collected at all post-intervention assessment time points (4, 8, and 12 months). Adverse events that were reported during active intervention 0-4 months, followed the same data collection protocol. A research coordinator collected information regarding the event onset date, ending date, specifics of the event (what was happening when it occurred, outcome, medications, follow up details).
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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 | Teens With Parents in PAC | 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 receive personalized feedback throughout the program. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hysterectomy | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle/Bone Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melanie K Bean | Virginia Commonwealth University | 804-527-4756 | melanie.bean@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2023 | Nov 10, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2023 | Feb 8, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Randomized Control Trial
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Assessors and the PI will be blind to treatment group.
|
| TEENS+Parent Weight Loss | Behavioral | 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. |
|
|
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.
| baseline to 4 month [intervention phase] and 4 month to 12 month [maintenance phase] |
| Physical Activity | 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. | Baseline, 4-, 8-, and 12-months |
| Physical Activity Change | 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). | 4-month to 12-month |
| Physical Activity Energy Expenditure | 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. | Baseline, 4-, 8-, and 12-months |
| Physical Activity Energy Expenditure Change | 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. | 4-month to 12-month |
| Dietary Intake | 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. | Baseline, 4-, 8-, and 12-months |
| Home Food Environment | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Parent Reported Parenting Style | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Role Modeling | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Restrictive Child Feeding Practices | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Overall Weight Control Practices | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Self Monitoring Weight Control Practices | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Dietary Choices Weight Control Practices | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Physical Activity Weight Control Practices | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Psychological Coping Weight Control Practices | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Adolescent Reported Responsiveness Parenting Style | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Adolescent Reported Demandingness Parenting Style | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Adolescent Reported Authoritative Parenting Style | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Home Exercise Environment | 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. | Baseline, 4-, 8-, and 12-months |
| Monitoring Child Feeding Practices | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Baseline, 2-, 4-, 8-, and 12-months |
| Parent Child Relationship | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Parent Self-efficacy | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| Social Support | 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. | Baseline, 2-, 4-, 8-, and 12-months |
| BG001 | Teens With Parents in PWL | 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 receive personalized feedback throughout the program. These adolescents have a participating parent in the Parent Weight Loss (PWL) treatment arm. |
| BG002 | Parents as Coaches (PAC) | 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. |
| BG003 | Parent Weight Loss (PWL) | 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 receive personalized feedback throughout the program. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Teens with parents in PWL | 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 receive personalized feedback throughout the program. These adolescents have a participating parent in the Parent Weight Loss (PWL) treatment arm. |
|
|
| Primary | Body Mass Index | 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. | Data presented includes the participants who completed body weight measurements at the respective time points. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline, 2-, 4-, 8-, and 12-months |
|
|
|
| Secondary | Parent Weight | 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. | Data presented includes the participants who completed body weight measurements at the respective time points. | Posted | Mean | Standard Deviation | Kilograms | Baseline, 2-, 4-, 8-, and 12-months |
|
|
|
| Secondary | Parent Weight Change | 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. | Data presented includes the participants who completed body weight measurements at the respective time points ([0 & 4m] and [4 & 12m]) and the change in weight between the two time points. | Posted | Mean | Standard Deviation | Kilograms | baseline to 4 month [intervention phase] and 4 month to 12 month [maintenance phase] |
|
|
|
| Secondary | Physical Activity | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | minutes per day | Baseline, 4-, 8-, and 12-months |
|
|
|
| Secondary | Physical Activity Change | 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). | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | minutes per day | 4-month to 12-month |
|
|
|
| Secondary | Physical Activity Energy Expenditure | 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. | Results include participants who met the minimum monitor wear time (3 weekdays and 1 weekend day) at the respective time point. | Posted | Mean | Standard Deviation | kilocalories per day | Baseline, 4-, 8-, and 12-months |
|
|
|
| Secondary | Physical Activity Energy Expenditure Change | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | kilocalories per day | 4-month to 12-month |
|
|
|
| Secondary | Dietary Intake | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | kilocalories per day | Baseline, 4-, 8-, and 12-months |
|
|
|
| Secondary | Home Food Environment | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
|
|
|
| Secondary | Parent Reported Parenting Style | 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. | Results include participants who completed the measure at the respective time point for each participating child. Parents who participated with 2 children responded to this measure twice. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months | Questionnaires | Questionnaires |
|
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| Secondary | Role Modeling | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
|
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| Secondary | Restrictive Child Feeding Practices | 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. | Results include participants who completed the measure at the respective time point for each participating child. Parents who participated with 2 children responded to this measure twice. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months | Questionnaires | Questionnaires |
|
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| Secondary | Overall Weight Control Practices | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
|
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| Secondary | Self Monitoring Weight Control Practices | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
|
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| Secondary | Dietary Choices Weight Control Practices | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
|
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| Secondary | Physical Activity Weight Control Practices | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
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| Secondary | Psychological Coping Weight Control Practices | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
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| Secondary | Adolescent Reported Responsiveness Parenting Style | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
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| Secondary | Adolescent Reported Demandingness Parenting Style | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
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| Secondary | Adolescent Reported Authoritative Parenting Style | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
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| Secondary | Home Exercise Environment | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4-, 8-, and 12-months |
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| Secondary | Monitoring Child Feeding Practices | 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. | Results include participants who completed the measure at the respective time point for each participating child. Parents who participated with 2 children responded to this measure twice. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months | Questionnaires | Questionnaires |
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| Other Pre-specified | Autonomy Support | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
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| Other Pre-specified | Parent Child Relationship | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
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| Other Pre-specified | Parent Self-efficacy | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
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| Other Pre-specified | Social Support | 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. | Results include participants who completed the measure at the respective time point. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2-, 4-, 8-, and 12-months |
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| 0 |
| 107 |
| 1 |
| 107 |
| 13 |
| 107 |
| EG001 | Teens With Parents in PWL | 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 receive personalized feedback throughout the program. | 0 | 104 | 2 | 104 | 17 | 104 |
| EG002 | Parents as Coaches (PAC) | 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. | 0 | 105 | 3 | 105 | 19 | 105 |
| EG003 | Parent Weight Loss (PWL) | 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. 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 receive personalized feedback throughout the program. | 0 | 102 | 5 | 102 | 13 | 102 |
| Asthma attack requiring hospitalization | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Severe headache requiring hospitalization | Nervous system disorders | Non-systematic Assessment |
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| Breast reduction surgery requiring hospitalization | Surgical and medical procedures | Systematic Assessment |
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| Transient ischemic attack | Nervous system disorders | Systematic Assessment |
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| Non-ST-elevation myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Chemotherapy for Non-Hodgkin's lymphoma | Immune system disorders | Systematic Assessment | Side effects from therapy resulted in hospitalization |
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| Psychiatric hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Gall bladder removal surgery | Surgical and medical procedures | Systematic Assessment |
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| Minor medical proceduree | Surgical and medical procedures | Systematic Assessment |
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Not provided
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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