Family Obesity Intervention: Motivational Interviewing and Community Support

NCT ID: NCT02425046

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-26
• Study Completion Date: 2020-07-02

Brief Summary

Low-income children and children of obese parents are at high risk of obesity. Effective interventions are needed to target these families to improve the health of the parents and prevent obesity in the children. The hypothesis is that an intervention that combines engagement of community organizations, motivational interviewing (MI, a technique proven to help people set goals that are personally meaningful), and resource mobilization will change diet and physical activity habits among disadvantaged families. This proposal grew from an established community-based participatory research (CBPR) partnership between the research team and community organizations that serve high minority (45-55%), low-income populations. Partners include a community health center, a food pantry network, a work-force training program, and other agencies. These partners designed and implemented a successful pilot project on which this proposal is based. The specific aims of this proposal are 1) To evaluate the efficacy of a family-targeted obesity intervention based on MI and resource-mobilization. Hypotheses: In comparison to control families, families participating in the intervention will demonstrate a) a reduction in BMI for adults, b) an increase in minutes of moderate physical activity and decreased sedentary time for both adults and children accelerometer), and c) a reduction in the number of obesity risk behaviors and an increase in obesity prevention behaviors among children. 2) To examine the mediators of intervention effects. 3) Identify the types of resources needed most often by intervention families to support lifestyle change. This randomized controlled trial includes 260 low-income families that contain at least one obese adult and one normal or overweight child between 6 and 12. The 12-month intervention has two elements. 1) A health coach will use MI to help families explore ambivalence toward and motivations for change and set goals for improving diet and physical activity. 2) To support goals, families will be connected with community agencies that can assist with general (e.g., financial) and goal specific resources (e.g., food, physical activity opportunities). Collaboration between organizations will streamline referrals, maximize resources, and facilitate access. Control families will get a basic screen for needs and information about available community resources. Outcomes are measured at baseline, 6, 12, and 18 months. This intervention is innovative in that it 1) focuses on lifestyle changes for the entire family and measures outcomes in adults and children, 2) combines MI focused on the entire family and community resource referrals specific to family needs and goals for change, 3) partners community organizations to coordinate resources for families, and 4) involves partners in all research phases via a CBPR approach. This contribution will be significant because the proposed intervention, if successful, can be replicated elsewhere and adapted to the local resource environment to address adult obesity and prevent childhood obesity in a high-risk population. The study will also identify the types of resources low-income families need to change diet and physical activity.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

health coaching and community screening

Family Health Coaching and community benefits screening

Group Type: EXPERIMENTAL

health coaching

Intervention Type: BEHAVIORAL

Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set.

community screening

Intervention Type: BEHAVIORAL

Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc.

community screening

community benefits screening only

Group Type: OTHER

community screening

Intervention Type: BEHAVIORAL

Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc.

Interventions

health coaching

Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set.

Intervention Type: BEHAVIORAL

community screening

Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• one parent must have a BMI of 30 or above, and be parent or guardian of at least one child
• between the ages of 6 and 12. Children this age are targeted because they benefit most from parental involvement
• are old enough to participate in family goal setting and activities, but young enough to be heavily influenced by family environment.
• a child must live with the obese parent at least 80% of the time.

Exclusion Criteria

• adults with obesity or target children with a medical condition or medication that significantly alters their

1. ability to follow the dietary recommendations (e.g., renal diet, severe food allergy, celiac disease)

2. mobility (e.g. bed bound or unable to participate in any sort of physical activity even with assistive devices), or

3. weight

• additionally we will exclude those who have a significant psychiatric disease, substance abuse disorder or cognitive impairment that would interfere with their ability to participate
• those with controlled or mild depression would not be excluded
• adults with hypertension, type II diabetes, or glucose intolerance will not be excluded, as advocated changes are consistent with their needs
• adults with obesity who are currently pregnant at baseline will be excluded because of their altered weight and dietary patterns. If the adult with obesity becomes pregnant during the intervention their family will be allowed to continue in the intervention but the pregnant adults' anthropometric data will not be collected.
• the intervention will intentionally target low-income families through recruitment site choices but will not exclude or include families based on income requirements.
• pregnant women will not be targeted but may be included if not the adult with obesity (see above).
• weight, height, waist circumference will not be collected on pregnant women.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Helena Laroche

OTHER

Sponsor Role: lead

Responsible Party

Helena Laroche

Physician, Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

helena Laroche, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

Primary Health Care, Inc

Des Moines, Iowa, United States

DMARC food pantries

Des Moines, Iowa, United States

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201406722

Identifier Type: -

Identifier Source: org_study_id