Family Obesity Intervention: Motivational Interviewing and Community Support

NCT02425046 | Completed Results DMC

• 1 other identifier: 201406722
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 3

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

Keywords

family

Outcome Measures

Primary Outcomes (4)

• Change in Adult Body Mass Index

  Change in Adult BMI from baseline to 12 months

  Outcome was assessed at baseline and 12 months and then calculated by subtracting the baseline value from the value at 12 months

• Change From Baseline in Duration of Daily Moderate to Vigorous Physical Activity

  Moderate to vigorous physical activity of the target adult measure by an accelerometer at baseline and 12 months. Calculated by subtracting the baseline amount from the 12 month value. The accelerometer is a wrist worn device - worn for 7 days - which measures motion in three directions - the amount of motion is then used assess what level of physical activity the participant is doing at each time interval. Vigorous - such as running, moderate such as fast walking, light such as walking slowly.

  measured at baseline and 12 months - outcome is the change from baseline to 12 months.

• Change in Score for Target Child Over 12months on the Family Nutrition and Physical Activity Scale

  Change in the Family Nutrition and Physical Activity Scale from baseline to 12 months - measure of behaviors relate to childhood obesity - parent reports for the target child. Scale scores possible range from 20 to 80. Higher indicates healthier behaviors.

  measured at baseline and 12 months

• Target Child - Change in Daily Moderate to Vigorous Physical Activity

  Change in minutes per day of moderate to vigorous physical activity of the target child as measure by accelerometer from baseline to 12 months. Calculated by subtracting the baseline amount from the 12 month value. The accelerometer is a wrist worn device - worn for 7 days - which measures motion in three directions - the amount of motion is then used assess what level of physical activity the participant is doing at each time interval. Vigorous - such as running, moderate such as fast walking, light such as walking slowly.

  baseline and 12 months

Secondary Outcomes (6)

• Adult - Change From Baseline in Number of 12 Ounce Cups or Cans Per Day of Sugar Sweetened Beverages

  baseline and 12 months

• Adult - Physical Activity Questionnaires:

  12 month

• Adult - Waist Circumference:

  12 months

• Child - BMI Z-score:

  12 months

• Child - Screen Time Questionnaire:

  12 months

Study Arms (2)

health coaching and community screening

EXPERIMENTAL

Family Health Coaching and community benefits screening

Behavioral: health coaching; Behavioral: community screening

community screening

OTHER

community benefits screening only

Behavioral: community screening

Interventions

health coaching BEHAVIORAL

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

health coaching and community screening

community screening 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; health coaching and community screening

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• adults with obesity or target children with a medical condition or medication that significantly alters their
• ability to follow the dietary recommendations (e.g., renal diet, severe food allergy, celiac disease)
• mobility (e.g. bed bound or unable to participate in any sort of physical activity even with assistive devices), or
• 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.

Sponsors & Collaborators

• Helena Laroche: lead

Study Sites (3)

Primary Health Care, Inc

Des Moines, Iowa, 50314, United States

Location

DMARC food pantries

Des Moines, Iowa, 50316, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Helena Laroche
• Organization: Center for Children's Healthy Lifestyles & Nutrition - Children's Mercy Hospital

hhlaroche@cmh.edu

(816) 234-9251

Study Officials

• helena Laroche, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician, Assistant Professor

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: April 23, 2015
• Study Start: March 26, 2015
• Primary Completion: October 9, 2018
• Study Completion: July 2, 2020
• Last Updated: February 5, 2024
• Results First Posted: February 5, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available after 18-month data has been processed and cleaned. Estimated date: June 2020 (subject to change, dependent on COVID-19).
• Access Criteria: Form will be reviewed by the PI, University of Iowa investigative team and the community advisory board and a decision about approval will be made. A University of Iowa research team member must be included in the analysis team to help with context and interpretation of data.

Locations

US (3)