NCT03643341

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

July 6, 2018

Last Update Submit

October 4, 2018

Conditions

Keywords

Family-basedCommunity-basedHealthy Weights

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (31)

  • Changes in BMI z-score calculated from measures of height and weight

    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)

    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)

  • +26 more secondary outcomes

Other Outcomes (1)

  • Process Evaluation of the EIP

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

Study Arms (2)

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.

Behavioral: Family Healthy Living

Wait-list control group

NO INTERVENTION

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

Interventions

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.

Family Healthy Living Intervention

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cameron Recreation Centre

Burnaby, British Columbia, V3J 1L6, Canada

RECRUITING

Strathcona Gardens Recreation Complex

Campbell River, British Columbia, V9W8C8, Canada

RECRUITING

Neighbourhood Learning Centre

Chilliwack, British Columbia, V2P2P8, Canada

RECRUITING

Kelowna Family YMCA

Kelowna, British Columbia, V1X2M9, Canada

RECRUITING

Cowichan Open Learning/Duncan Elementary School

North Cowichan, British Columbia, V9L2E6, Canada

RECRUITING

YMCA Northern BC

Prince George, British Columbia, Canada

RECRUITING

Tong Louie YMCA

Surrey, British Columbia, V3S7S6, Canada

RECRUITING

Surrey Sport & Leisure Complex

Surrey, British Columbia, V4N0E9, Canada

RECRUITING

Langara Family YMCA

Vancouver, British Columbia, V5Y2Z5, Canada

RECRUITING

Juan de Fuca Recreation Centre

Victoria, British Columbia, V9B1J1, Canada

RECRUITING

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

ObesityHealth BehaviorChild BehaviorPediatric ObesityNutrition DisordersBody Weight

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Karen Strange, PhD

    Childhood Obesity Foundation

    STUDY DIRECTOR

Central Study Contacts

Patti-Jean Naylor, PhD

CONTACT

Sam Liu, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 6, 2018

First Posted

August 22, 2018

Study Start

October 10, 2018

Primary Completion

January 31, 2019

Study Completion

March 31, 2019

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Individual participant data will only be share with co-investigators

Locations