Children's Healthy Living Community Randomized Trial (CHL)

University of Hawaii

Status: Completed

Conditions: Central Obesity; Obesity; Acanthosis Nigricans

Treatments: Other: Delayed Optimized CHL program; Other: CHL program

Study type: Interventional

Funder types: Other

Identifiers

NCT01881373

2011-68001-30335 (Other Grant/Funding Number)

USDA 2011-68001-30335

2018-69001-27551 (Other Grant/Funding Number)

Details and patient eligibility

About

The goal is to build social/cultural, political/economic, and physical/built environments that will promote active play and intake of healthy food to prevent young child obesity in the Pacific Region. Our methods will support local culture in order to achieve this goal in these remote, underserved native populations. CHL will engage the community, and focus on capacity building and sustainable environmental change.

The focus of the CHL community-based program is to promote healthy eating and to increase physical activity. In order to demonstrate effectiveness, the investigators will recruit and measure children in six communities selected in each of our jurisdictions in the Pacific. These represent intervention communities, comparison communities, and temporal communities.

Full description

The specific objectives of our study are as follows.

Objective. Decrease the prevalence of young child overweight and obesity; and its functional outcomes (decrease acanthosis nigricans, and increase sleep; increase moderate to vigorous physical activity and decrease sedentary behavior (screen time); increase healthy eating (fruit and vegetable intake, water intake; decrease sweetened beverage intake), through community-based primary prevention environmental interventions in the Pacific region.

Objective. Measure 2-8-year-old children at baseline and 24 months in selected communities to track behaviors and anthropometry that indicate healthy eating, physical activity, and BMI.

Objective. Measure 2-8 year old children at 78 months in the selected communities to determine the long term effect of the CHL program.

Enrollment: 9,840 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Community criteria

Four (4) to six (6) communities in each of five (5) jurisdictions (Alaska, American Samoa, Commonwealth of Northern Mariana Islands, Guam & Hawai'i) chosen for community randomized program based on:

• 2000 U.S. Census criteria

  • >1000 people
  • >25% Native population,
  • >10% under 5y

• CHL Staff Community Evaluation

  • Sufficient Head Start/preschool, kindergarten
  • Children live & go to school in area
  • Separation between communities to allow testing
  • Access for CHL
  • Sufficient community cohesiveness
  • Sufficient settings for program (community centers, parks, stores...)

• Child criteria • 2-10 years of age

Exclusion criteria

• Child criteria

  • Known orthopedic, psychological or neurologic impairments that prevent physical activity
  • Presence or history of any metabolic or chronic health problems known to affect intermediary metabolism (e.g. untreated thyroid disease, cancer, hepatic disease, renal disease, diabetes, cardiovascular disease, hypertension)
  • Irregular use of prescription or over-the-counter medications known to affect appetite, food intake or intermediary metabolism (e.g. appetite suppressants, lithium, antidepressants, etc.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,840 participants in 3 patient groups

CHL program

Experimental group

Description:

Multiple component environmentally focused intervention designed with a community engagement process.

Treatment:

Other: CHL program

Delayed Optimized CHL program

Other group

Description:

Comparison community that participated in community engagement process and received delayed optimized program.

Treatment:

Other: Delayed Optimized CHL program

Temporal

No Intervention group

Description:

Communities assessed for temporal trends in anthropometry.