Family Healthy Living Early Intervention Program

NCT ID: NCT03643341

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-10

Study Completion Date

2019-03-31

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.

Detailed Description

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Conditions

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Obesity Health Behavior Child Behavior Child Obesity Nutrition Disorders Body Weight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Family Healthy Living

Intervention Type BEHAVIORAL

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.

Wait-list control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Childhood Obesity Foundation

OTHER

Sponsor Role collaborator

University of Victoria

OTHER

Sponsor Role lead

Responsible Party

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Patti-Jean Naylor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Strange, PhD

Role: STUDY_DIRECTOR

Childhood Obesity Foundation

Locations

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Cameron Recreation Centre

Burnaby, British Columbia, Canada

Site Status RECRUITING

Strathcona Gardens Recreation Complex

Campbell River, British Columbia, Canada

Site Status RECRUITING

Neighbourhood Learning Centre

Chilliwack, British Columbia, Canada

Site Status RECRUITING

Kelowna Family YMCA

Kelowna, British Columbia, Canada

Site Status RECRUITING

Cowichan Open Learning/Duncan Elementary School

North Cowichan, British Columbia, Canada

Site Status RECRUITING

YMCA Northern BC

Prince George, British Columbia, Canada

Site Status RECRUITING

Tong Louie YMCA

Surrey, British Columbia, Canada

Site Status RECRUITING

Surrey Sport & Leisure Complex

Surrey, British Columbia, Canada

Site Status RECRUITING

Langara Family YMCA

Vancouver, British Columbia, Canada

Site Status RECRUITING

Juan de Fuca Recreation Centre

Victoria, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Patti-Jean Naylor, PhD

Role: CONTACT

250-721-8373

Sam Liu, PhD

Role: CONTACT

250-721-8392

Facility Contacts

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Marisa Plasterer

Role: primary

Debra Wilson

Role: primary

Serena Bring

Role: primary

Kelley Taylor

Role: primary

Jill Amy

Role: primary

Melissa Cailleaux

Role: primary

Serena Bring

Role: primary

Caitlin Davies

Role: primary

Serena Bring

Role: primary

Nicky Brown

Role: primary

Geoff Welham

Role: backup

References

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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.

Reference Type DERIVED
PMID: 33370164 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31676642 (View on PubMed)

Other Identifiers

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BC18-024

Identifier Type: -

Identifier Source: org_study_id

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