Clinical trial NCT02425046: Family Obesity Intervention: Motivational Interviewing and Community Support
Official title: Family Obesity Intervention: Motivational Interviewing and Community Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: family
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 472
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
* no data will be collected from non-target children who meet the exclusion criteria.
* 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.

Primary outcomes:
measure: Change in Adult Body Mass Index
timeFrame: Outcome was assessed at baseline and 12 months and then calculated by subtracting the baseline value from the value at 12 months
measure: Change From Baseline in Duration of Daily Moderate to Vigorous Physical Activity
timeFrame: measured at baseline and 12 months - outcome is the change from baseline to 12 months.
measure: Change in Score for Target Child Over 12months on the Family Nutrition and Physical Activity Scale
timeFrame: measured at baseline and 12 months
measure: Target Child - Change in Daily Moderate to Vigorous Physical Activity
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Adult - Change From Baseline in Number of 12 Ounce Cups or Cans Per Day of Sugar Sweetened Beverages
timeFrame: baseline and 12 months
measure: Adult - Physical Activity Questionnaires:
timeFrame: 12 month
measure: Adult - Waist Circumference:
timeFrame: 12 months
measure: Child - BMI Z-score:
timeFrame: 12 months
measure: Child - Screen Time Questionnaire:
timeFrame: 12 months
measure: Child -Dietary Measures: Change in 12 Ounce Cups Per Day of Sugar Sweetened Beverages
timeFrame: baseline and 12 months
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Primary Health Care, Inc
state: Iowa
city: Des Moines
country: United States
facility: DMARC food pantries
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: helena Laroche, MD
role: PRINCIPAL_INVESTIGATOR
References: