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临床试验/NCT03643341
NCT03643341Unknown不适用

Family-based, Healthy Living Intervention for Children With Overweight and Obesity and Their Families

University of Victoria19 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年10月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
105
试验地点
19
主要终点
Changes in BMI calculated from measures of height and weight

研究概览

简要总结

The Childhood Healthy Weights Early Intervention Program (EIP) is a family-based pilot program that will promote healthy lifestyle practices for families whose children are off the healthy weight trajectory (e.g., BMI ≥ 85th percentile for age and sex) that do not need the intensive services of medically supervised programs. It is a lifestyle behaviour approach for promoting healthy weights in children. The EIP program consists of 10 weekly intervention sessions (1.5 hours per session) followed by 4 maintenance sessions and is age specific (age 8-12). During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. The program will be integrated and aligned with existing BC-specific childhood healthy weights programs (e.g. the HealthLinkBC Eating and Activity Program for Kids). The EIP pilot will run from October-December 2018 with 8 child programs (age 8-12). Participants who do not qualify for this program (e.g., BMI ≤ 85th percentile for age and sex) will be offered a 10 week online program which is similar in educational content as the EIP program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child with BMI ≥ 85th percentile for age and sex
  • Child is accompanied by a parent or legal guardian
  • At least one member of the family have to be able to speak and read English
  • Family agrees to attend group meetings over 10 weeks

排除标准

  • Child unavailable to attend group weekly sessions
  • Parent or guardian unavailable to attend group weekly sessions
  • Participating child or parent, according to parent report, has medical condition contraindicating mild energy restriction or moderate physical activity, and medical clearance was not obtained

研究组 & 干预措施

Family Healthy Living Intervention

Experimental

Children aged 8-12 and at least one caregiver will meet for 10 weekly face-to-face and online intervention sessions (1.5 hours per session). Four biweekly maintenance sessions will follow the main program.

干预措施: Family Healthy Living (Behavioral)

Wait-list control group

No Intervention

Children aged 8-12 will be randomly assigned to the wait-list control group until after the study.

结局指标

主要结局

Changes in BMI calculated from measures of height and weight

时间窗: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)

Measures of height and weight will be obtained from all children. BMI will be calculated as weight (kilograms) divided by height (meters) squared, adjusted for child age and sex.

次要结局

  • Changes in Physical Activity Engagement assessed by the Physical Activity Questionnaire for Children (PAQ-C)(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Physical Activity Motivation and Confidence assessed by the Canadian Assessment of Physical Literacy (CAPL-2) Physical Activity Motivation and Confidence subscale(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Physical Activity assessed by the PACE Adolescent Psychosocial Measures(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Sedentary Habits assessed by the PACE Adolescent Psychosocial Measures(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in BMI z-score calculated from measures of height and weight(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Fundamental Movement Skills (FMS) assessed by the Canadian Agility and Movement Skill Assessment (CAMSA)(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Dietary Behaviours assessed by the LiGHT questionnaire (7-day recall questions retrieved from CDC BRFSS surveys)(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Healthy Eating Outcome Expectations assessed by the Power Play! Survey.(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Dietary Behaviors Self-efficacy assessed by the PACE Adolescent Psychosocial Measures(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Healthy Eating Motivation assessed by the FLASHE questionnaire(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Perceived Cooking Skill assessed by the Cooking with Kids questionnaire(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Self-esteem assessed by the Project EAT survey(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Gratitude assessed by the Gratitude Adjective Checklist(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Self-compassion by the Self-compassion Scale Short Form(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Sleep Habits assessed by the FLASHE questionnaire(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Parent Feeding Practices assessed by questions drawn from the FLASHES-EAT surveys.(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Parent Feeding Practices assessed by a question drawn from the CANPOWER questionnaire(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Parent Feeding Practices assessed by the Parent Support of Healthy Eating questionnaire(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Structure of the Home Food Environment assessed by the Fruit and Vegetable At Home Survey For Parents.(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Parent's Personal Dietary Behaviours are assessed by the FLASHE questionnaire.(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Parent Food Preparation Self-efficacy assessed with two questions drawn from the FLASHES-EAT survey.(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Behavioral Regulation of Supporting Child's Healthy Eating assessed by the Action Control of Parent Support Behaviour(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Healthy Eating Habits assessed by the automaticity subscale of Self-Report Index of Habit.(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Healthy Eating Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Parent Physical Activity Support assessed by the ParticipACTION 24hr Guidelines Survey(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Parent Physical Activity Self-efficacy assessed by the LiGHT study questionnaire(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Behavioral Regulation of Supporting Child's Physical Activity assessed by the Action Control of Parent Support Behaviour(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Physical Activity Habit assessed by the automaticity subscale of the Self-Report Index of Habit(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Physical Activity Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Parent Support for Child Sleep Habits assessed by the ParticipACTION 24hr Guidelines Survey(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))
  • Changes in Child Quality of Life assessed by the Pediatric Quality of Life Inventory(Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patti-Jean Naylor

Professor

University of Victoria

研究点 (19)

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