Family Healthy Living Early Intervention Program

Overview

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.

Full Title of Study: “Family-based, Healthy Living Intervention for Children With Overweight and Obesity and Their Families”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Investigator)
  • Study Primary Completion Date: January 31, 2019

Interventions

  • Behavioral: Family Healthy Living
    • Children aged 8-12 and at least one caregiver will meet for 10 weekly intervention sessions (1.5 hours per session), and 4 extra sessions to be chosen by families and intervention Leaders. During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. Four biweekly maintenance sessions will follow the main program.

Arms, Groups and Cohorts

  • Experimental: Family Healthy Living Intervention
    • 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.
  • No Intervention: Wait-list control group
    • Children aged 8-12 will be randomly assigned to the wait-list control group until after the study.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in BMI calculated from measures of height and weight
    • Time Frame: 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.

Secondary Measures

  • Changes in BMI z-score calculated from measures of height and weight
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Measures of height and weight will be obtained from all children, BMI z-scores (standard deviation) will be calculated.
  • Changes in Physical Activity Engagement assessed by the Physical Activity Questionnaire for Children (PAQ-C)
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Self-reported child usual physical activity engagement will be assessed by PAQ-C 7-day physical activity recall
  • Changes in Physical Activity Motivation and Confidence assessed by the Canadian Assessment of Physical Literacy (CAPL-2) Physical Activity Motivation and Confidence subscale
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. The Motivation and Confidence sub-scale of CAPL-2 assesses physical activity predilection and adequacy, perceived physical activity intrinsic motivation and competence
  • Changes in Physical Activity assessed by the PACE Adolescent Psychosocial Measures
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. The PACE Adolescent Psychosocial Measures assesses physical activity, confidence, and family support
  • Changes in Sedentary Habits assessed by the PACE Adolescent Psychosocial Measures
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. The PACE Adolescent Psychosocial Measures assesses sedentary habits, confidence, and family support
  • Changes in Fundamental Movement Skills (FMS) assessed by the Canadian Agility and Movement Skill Assessment (CAMSA)
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • CAMSA is the FMS course from the Canadian Assessment of Physical Literacy (CAPL-2) that assesses two-foot jumping, sliding, catch, throw, skip, one-foot hop, and kick. Children will observe two demonstrations, will complete two trials, and two timed and scored trials.
  • Changes in Dietary Behaviours assessed by the LiGHT questionnaire (7-day recall questions retrieved from CDC BRFSS surveys)
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. Dietary behaviours such as fruits, vegetables, fruit juice, soda, fruit-flavored beverages, and pastries intake will be assessed by the 7-day dietary recall
  • Healthy Eating Outcome Expectations assessed by the Power Play! Survey.
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. Knowledge or ideas about what will happen when regularly consuming fruits and vegetables.
  • Changes in Dietary Behaviors Self-efficacy assessed by the PACE Adolescent Psychosocial Measures
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. Self-efficacy to increase fruit and vegetable intake, and to reduce the intake of sugary beverages and sweet/salty snack foods will be assessed.
  • Changes in Healthy Eating Motivation assessed by the FLASHE questionnaire
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. Motivation for eating fruits and vegetables will be assessed. Motivation for limiting sweet/salty snack foods and sugary drinks will also be assessed.
  • Changes in Perceived Cooking Skill assessed by the Cooking with Kids questionnaire
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. Assesses child’s ability to prepare and cook food
  • Changes in Self-esteem assessed by the Project EAT survey
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. Self-esteem will be assessed by the Project EAT survey
  • Changes in Gratitude assessed by the Gratitude Adjective Checklist
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. Changes in Gratitude assessed using the Gratitude Adjective Checklist
  • Changes in Self-compassion by the Self-compassion Scale Short Form
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. Changes in Gratitude assessed using the Self-compassion Scale Short Form
  • Changes in Sleep Habits assessed by the FLASHE questionnaire
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Child questionnaire. Usual hours of sleep will be self-reported by the child
  • Changes in Parent Feeding Practices assessed by questions drawn from the FLASHES-EAT surveys.
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. The FLASHES-EAT survey assess how parents communicate with their children regarding food and dietary habits and how they organize and monitor the home food environment.
  • Changes in Parent Feeding Practices assessed by a question drawn from the CANPOWER questionnaire
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. The CANPOWER questionnaire assesses whether or not parents encourage their child to participate in healthy lifestyle behaviors (eating fruits and vegetables)
  • Changes in Parent Feeding Practices assessed by the Parent Support of Healthy Eating questionnaire
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. This questionnaire assess each parent’s specific behavioral constructs (affective attitude, instrumental attitude) in regards to supporting their child’s healthy eating behaviors.
  • Changes in Structure of the Home Food Environment assessed by the Fruit and Vegetable At Home Survey For Parents.
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. The Fruit and Vegetable At Home Survey For Parents assess the availability and accessibility of fruits and vegetables within the home.
  • Changes in Parent’s Personal Dietary Behaviours are assessed by the FLASHE questionnaire.
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. The FLASHE questionnaire assess parents’ fruit and vegetable intake in addition to their consumption of food away from the home (e.g. fast-food restaurants, work cafeteria).
  • Changes in Parent Food Preparation Self-efficacy assessed with two questions drawn from the FLASHES-EAT survey.
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. The questions drawn from the FLASHES-EAT survey assess parents’ confidence level with preparing a variety of fruits and vegetables as well as their level of confidence preparing family meals with their children.
  • Changes in Behavioral Regulation of Supporting Child’s Healthy Eating assessed by the Action Control of Parent Support Behaviour
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. This questionnaire assess whether or not parents set goals and make regular plans to support their child’s healthy eating behaviors.
  • Changes in Healthy Eating Habits assessed by the automaticity subscale of Self-Report Index of Habit.
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. The Self-Report Index of Habit assess whether or not parents believe that preparing and eating healthy meals is something their family does habitually.
  • Changes in Healthy Eating Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. These questions assess how parents view their own and their family’s dietary behaviors and food choices.
  • Changes in Parent Physical Activity Support assessed by the ParticipACTION 24hr Guidelines Survey
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. Changes in Parent Physical Activity Support will be assessed by the ParticipACTION 24hr Guidelines Survey
  • Changes in Parent Physical Activity Self-efficacy assessed by the LiGHT study questionnaire
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. Changes in Parent Physical Activity Self-efficacy assessed by the LiGHT study questionnaire
  • Changes in Behavioral Regulation of Supporting Child’s Physical Activity assessed by the Action Control of Parent Support Behaviour
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. This questionnaire assess whether or not parents set goals and make regular plans to support their child’s physical activity participation.
  • Changes in Physical Activity Habit assessed by the automaticity subscale of the Self-Report Index of Habit
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. The Self-Report Index of Habit assess whether or not parents believe that participating in physical activity is something their family does habitually.
  • Changes in Physical Activity Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. These questions assess how parents view their own and their family’s physical activity participation.
  • Changes in Parent Support for Child Sleep Habits assessed by the ParticipACTION 24hr Guidelines Survey
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. Changes in Parent Support for Child Sleep Habits will be assessed by the ParticipACTION 24hr Guidelines Survey
  • Changes in Child Quality of Life assessed by the Pediatric Quality of Life Inventory
    • Time Frame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
    • Parent questionnaire. Changes in Child Quality of Life will be assessed by the Pediatric Quality of Life Inventory

Participating in This Clinical Trial

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Victoria
  • Collaborator
    • Childhood Obesity Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Patti-Jean Naylor, Professor – University of Victoria
  • Overall Official(s)
    • Karen Strange, PhD, Study Director, Childhood Obesity Foundation
  • Overall Contact(s)
    • Patti-Jean Naylor, PhD, 250-721-8373, pjnaylor@uvic.ca

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