Family Healthy Living Early Intervention Program

Study Overview
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Brief Summary
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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.

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

Conditions
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Health Behavior, Child Behavior, Child Obesity, Nutrition Disorders, Body Weight, Obesity

Intervention / Treatment
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* Behavioral: Family Healthy Living


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Healthy Living Intervention<br>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. | Behavioral: Family Healthy Living<br>* 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.<br>|
| No Intervention: Wait-list control group<br>Children aged 8-12 will be randomly assigned to the wait-list control group until after the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in BMI calculated from measures of height and weight | 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. | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in BMI z-score calculated from measures of height and weight | Measures of height and weight will be obtained from all children, BMI z-scores (standard deviation) will be calculated. | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Physical Activity Engagement assessed by the Physical Activity Questionnaire for Children (PAQ-C) | Self-reported child usual physical activity engagement will be assessed by PAQ-C 7-day physical activity recall | 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 | Child questionnaire. The Motivation and Confidence sub-scale of CAPL-2 assesses physical activity predilection and adequacy, perceived physical activity intrinsic motivation and competence | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Physical Activity assessed by the PACE Adolescent Psychosocial Measures | Child questionnaire. The PACE Adolescent Psychosocial Measures assesses physical activity, confidence, and family support | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Sedentary Habits assessed by the PACE Adolescent Psychosocial Measures | Child questionnaire. The PACE Adolescent Psychosocial Measures assesses sedentary habits, confidence, and family support | 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) | 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. | 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) | 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 | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Healthy Eating Outcome Expectations assessed by the Power Play! Survey. | Child questionnaire. Knowledge or ideas about what will happen when regularly consuming fruits and vegetables. | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Dietary Behaviors Self-efficacy assessed by the PACE Adolescent Psychosocial Measures | 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. | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Healthy Eating Motivation assessed by the FLASHE questionnaire | 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. | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Perceived Cooking Skill assessed by the Cooking with Kids questionnaire | Child questionnaire. Assesses child's ability to prepare and cook food | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Self-esteem assessed by the Project EAT survey | Child questionnaire. Self-esteem will be 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 | Child questionnaire. Changes in Gratitude assessed using 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 | Child questionnaire. Changes in Gratitude assessed using 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 | Child questionnaire. Usual hours of sleep will be self-reported by the child | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Parent Feeding Practices assessed by questions drawn from the FLASHES-EAT surveys. | 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. | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Parent Feeding Practices assessed by a question drawn from the CANPOWER questionnaire | Parent questionnaire. The CANPOWER questionnaire assesses whether or not parents encourage their child to participate in healthy lifestyle behaviors (eating fruits and vegetables) | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Parent Feeding Practices assessed by the Parent Support of Healthy Eating questionnaire | 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. | 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. | Parent questionnaire. The Fruit and Vegetable At Home Survey For Parents assess the availability and accessibility of fruits and vegetables within the home. | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Parent's Personal Dietary Behaviours are assessed by the FLASHE questionnaire. | 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). | 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. | 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. | 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 | Parent questionnaire. This questionnaire assess whether or not parents set goals and make regular plans to support their child's healthy eating behaviors. | 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. | 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. | 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. | Parent questionnaire. These questions assess how parents view their own and their family's dietary behaviors and food choices. | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 
| Changes in Parent Physical Activity Support assessed by the ParticipACTION 24hr Guidelines Survey | Parent questionnaire. Changes in Parent Physical Activity Support will be 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 | Parent questionnaire. 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 | Parent questionnaire. This questionnaire assess whether or not parents set goals and make regular plans to support their child's physical activity participation. | 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 | 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. | 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. | Parent questionnaire. These questions assess how parents view their own and their family's physical activity participation. | 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 | Parent questionnaire. Changes in Parent Support for Child Sleep Habits will be 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 | Parent questionnaire. Changes in Child Quality of Life will be assessed by the Pediatric Quality of Life Inventory | Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family-based, Community-based, Healthy Weights