Clinical trial NCT03643341: Family Healthy Living Early Intervention Program
Official title: Family-based, Healthy Living Intervention for Children With Overweight and Obesity and Their Families
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Health Behavior
Child Behavior
Child Obesity
Nutrition Disorders
Body Weight
Keywords: Family-based
Community-based
Healthy Weights
Lead sponsor: University of Victoria
Sponsor class: OTHER
Collaborators: name: Childhood Obesity Foundation
First posted: 2018-08-22
Enrollment: 105
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in BMI calculated from measures of height and weight
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Secondary outcomes:
measure: Changes in BMI z-score calculated from measures of height and weight
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Physical Activity Engagement assessed by the Physical Activity Questionnaire for Children (PAQ-C)
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Physical Activity Motivation and Confidence assessed by the Canadian Assessment of Physical Literacy (CAPL-2) Physical Activity Motivation and Confidence subscale
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Physical Activity assessed by the PACE Adolescent Psychosocial Measures
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Sedentary Habits assessed by the PACE Adolescent Psychosocial Measures
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Fundamental Movement Skills (FMS) assessed by the Canadian Agility and Movement Skill Assessment (CAMSA)
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Dietary Behaviours assessed by the LiGHT questionnaire (7-day recall questions retrieved from CDC BRFSS surveys)
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Healthy Eating Outcome Expectations assessed by the Power Play! Survey.
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Dietary Behaviors Self-efficacy assessed by the PACE Adolescent Psychosocial Measures
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Healthy Eating Motivation assessed by the FLASHE questionnaire
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Perceived Cooking Skill assessed by the Cooking with Kids questionnaire
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Self-esteem assessed by the Project EAT survey
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Gratitude assessed by the Gratitude Adjective Checklist
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Self-compassion by the Self-compassion Scale Short Form
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Sleep Habits assessed by the FLASHE questionnaire
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Parent Feeding Practices assessed by questions drawn from the FLASHES-EAT surveys.
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Parent Feeding Practices assessed by a question drawn from the CANPOWER questionnaire
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Parent Feeding Practices assessed by the Parent Support of Healthy Eating questionnaire
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Structure of the Home Food Environment assessed by the Fruit and Vegetable At Home Survey For Parents.
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Parent's Personal Dietary Behaviours are assessed by the FLASHE questionnaire.
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Parent Food Preparation Self-efficacy assessed with two questions drawn from the FLASHES-EAT survey.
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Behavioral Regulation of Supporting Child's Healthy Eating assessed by the Action Control of Parent Support Behaviour
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Healthy Eating Habits assessed by the automaticity subscale of Self-Report Index of Habit.
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Healthy Eating Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Parent Physical Activity Support assessed by the ParticipACTION 24hr Guidelines Survey
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Parent Physical Activity Self-efficacy assessed by the LiGHT study questionnaire
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Behavioral Regulation of Supporting Child's Physical Activity assessed by the Action Control of Parent Support Behaviour
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Physical Activity Habit assessed by the automaticity subscale of the Self-Report Index of Habit
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Physical Activity Identity assessed by the Role-Identity subscale from the Exercise Identity Scale.
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Parent Support for Child Sleep Habits assessed by the ParticipACTION 24hr Guidelines Survey
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
measure: Changes in Child Quality of Life assessed by the Pediatric Quality of Life Inventory
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Other outcomes:
measure: Process Evaluation of the EIP
timeFrame: Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Locations:
city: Burnaby
country: Canada
facility: Cameron Recreation Centre
state: British Columbia
city: Campbell River
country: Canada
facility: Strathcona Gardens Recreation Complex
state: British Columbia
city: Chilliwack
country: Canada
facility: Neighbourhood Learning Centre
state: British Columbia
city: Kelowna
country: Canada
facility: Kelowna Family YMCA
state: British Columbia
city: North Cowichan
country: Canada
facility: Cowichan Open Learning/Duncan Elementary School
state: British Columbia
city: Prince George
country: Canada
facility: YMCA Northern BC
state: British Columbia
city: Surrey
country: Canada
facility: Tong Louie YMCA
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Sport & Leisure Complex
state: British Columbia
city: Vancouver
country: Canada
facility: Langara Family YMCA
state: British Columbia
city: Victoria
country: Canada
facility: Juan de Fuca Recreation Centre
state: British Columbia
Study officials:
affiliation: Childhood Obesity Foundation
name: Karen Strange, PhD
role: STUDY_DIRECTOR
References:
citation: Perdew M, Liu S, Rhodes R, Ball GDC, Masse LC, Hartrick T, Strange K, Naylor PJ. The Effectiveness of a Blended In-Person and Online Family-Based Childhood Obesity Management Program. Child Obes. 2021 Jan;17(1):58-67. doi: 10.1089/chi.2020.0236. Epub 2020 Dec 23.
citation: Liu S, Marques IG, Perdew MA, Strange K, Hartrick T, Weismiller J, Ball GDC, Masse LC, Rhodes R, Naylor PJ. Family-based, healthy living intervention for children with overweight and obesity and their families: a 'real world' trial protocol using a randomised wait list control design. BMJ Open. 2019 Oct 31;9(10):e027183. doi: 10.1136/bmjopen-2018-027183.