Parent Involvement in Adolescent Obesity Treatment

Virginia Commonwealth University418 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

418

Conditions

Pediatric Obesity

Interventions

TEENS+Parents as CoachesBEHAVIORAL

Parents as Coaches teaches parenting strategies to facilitate healthy weight loss in adolescent children; adolescents are in a group based behavioral weight management treatment.

TEENS+Parent Weight LossBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Richmond at VCU Healthy Lifestyles Center

Henrico, Virginia, United States

Outcomes

Primary Outcomes

Body Mass Index (BMI) Change

Body Mass Index (BMI) change (kg/m2; adolescent) during the maintenance phase (4-month to 12-month).

Time frame: 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.

Time frame: Baseline, 2-, 4-, 8-, and 12-months

Secondary Outcomes

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.

Time frame: Baseline, 2-, 4-, 8-, and 12-months

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.

Time frame: 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.

Time frame: Baseline, 4-, 8-, and 12-months

Physical Activity Change

Data from ClinicalTrials.gov

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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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 2-, 4-, 8-, and 12-months