Family Healthy Living Early Intervention Program

Obesity Clinical Trial

— EIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03643341
• Other study ID #: BC18-024
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: October 2018
• Source: University of Victoria
• Contact: Patti-Jean Naylor, PhD
• Phone: 250-721-8373
• Email: pjnaylor[@]uvic.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: March 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Child Behavior
• Child Obesity
• Health Behavior
• Nutrition Disorders
• Obesity
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Canada	Cameron Recreation Centre	Burnaby	British Columbia
Canada	Strathcona Gardens Recreation Complex	Campbell River	British Columbia
Canada	Neighbourhood Learning Centre	Chilliwack	British Columbia
Canada	Kelowna Family YMCA	Kelowna	British Columbia
Canada	Cowichan Open Learning/Duncan Elementary School	North Cowichan	British Columbia
Canada	YMCA Northern BC	Prince George	British Columbia
Canada	Surrey Sport & Leisure Complex	Surrey	British Columbia
Canada	Tong Louie YMCA	Surrey	British Columbia
Canada	Langara Family YMCA	Vancouver	British Columbia
Canada	Juan de Fuca Recreation Centre	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of Victoria	Childhood Obesity Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process Evaluation of the EIP	Evaluate the reach, implementation, and sustainability of the EIP. Examine if the EIP is reaching a broad demographic, if families and staff are satisfied with the EIP, if the EIP is being implemented as intended across the pilot sites and to explore the facilitators and barriers to implementation.	Baseline, post-intervention (10 weeks), and post-maintenance (18 weeks)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)