The Role of Parents in Adolescent Obesity Treatment: Randomized Control Trial of TEENS+
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI) Change
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessors and the PI will be blind to treatment group.
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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:
- •BMI ≥ 25 kg/m2
- •Must reside with the adolescent
排除标准
- •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
结局指标
主要结局
Body Mass Index (BMI) Change
时间窗: 4 months to 12 month [follow up phase]
Body Mass Index (BMI) change (kg/m2; adolescent) during the maintenance phase (4-month to 12-month).
Body Mass Index
时间窗: Baseline, 2-, 4-, 8-, and 12-months
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.
次要结局
- Physical Activity Energy Expenditure Change(4-month to 12-month)
- Dietary Intake(Baseline, 4-, 8-, and 12-months)
- Home Food Environment(Baseline, 2-, 4-, 8-, and 12-months)
- Parent Weight(Baseline, 2-, 4-, 8-, and 12-months)
- Parent Weight Change(baseline to 4 month [intervention phase] and 4 month to 12 month [maintenance phase])
- Physical Activity(Baseline, 4-, 8-, and 12-months)
- Physical Activity Change(4-month to 12-month)
- Physical Activity Energy Expenditure(Baseline, 4-, 8-, and 12-months)
- Parent Reported Parenting Style(Baseline, 2-, 4-, 8-, and 12-months)
- Role Modeling(Baseline, 2-, 4-, 8-, and 12-months)
- Restrictive Child Feeding Practices(Baseline, 2-, 4-, 8-, and 12-months)
- Overall Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
- Self Monitoring Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
- Dietary Choices Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
- Physical Activity Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
- Psychological Coping Weight Control Practices(Baseline, 2-, 4-, 8-, and 12-months)
- Adolescent Reported Responsiveness Parenting Style(Baseline, 2-, 4-, 8-, and 12-months)
- Adolescent Reported Demandingness Parenting Style(Baseline, 2-, 4-, 8-, and 12-months)
- Adolescent Reported Authoritative Parenting Style(Baseline, 2-, 4-, 8-, and 12-months)
- Home Exercise Environment(Baseline, 4-, 8-, and 12-months)
- Monitoring Child Feeding Practices(Baseline, 2-, 4-, 8-, and 12-months)