Family Obesity Intervention: Motivational Interviewing and Community Support
Primary Purpose
Obesity
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
health coaching
community screening
Sponsored by

About this trial
This is an interventional prevention trial for Obesity focused on measuring family
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:
obese adults or index 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
- no data will be collected from nonindex children who meet the exclusion criteria.
- obese adults who are currently pregnant at baseline will be excluded because of their altered weight and dietary patterns. If the obese adult 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 obese adult (see above).
- weight, height, waist circumference and bioelectrical impedance will not be collected on pregnant women.
Sites / Locations
- Primary Health Care, Inc
- DMARC food pantries
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
health coaching and community screening
community screening
Arm Description
Family Health Coaching and community benefits screening
community benefits screening only
Outcomes
Primary Outcome Measures
Change in Adult Body Mass Index
Change in adult - physical activity
Change in target child - Family Nutrition and Physical Activity Scale
Change in target child - physical activity
Secondary Outcome Measures
adult - dietary intake
adult - Physical activity questionnaires:
adult - Waist Circumference:
child - BMI z-score:
child - Screen time questionnaire:
child-Dietary measures:
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02425046
Brief Title
Family Obesity Intervention: Motivational Interviewing and Community Support
Official Title
Family Obesity Intervention: Motivational Interviewing and Community Support
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 26, 2015 (Actual)
Primary Completion Date
October 9, 2018 (Actual)
Study Completion Date
July 2, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Helena Laroche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
family
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
472 (Actual)
8. Arms, Groups, and Interventions
Arm Title
health coaching and community screening
Arm Type
Experimental
Arm Description
Family Health Coaching and community benefits screening
Arm Title
community screening
Arm Type
Other
Arm Description
community benefits screening only
Intervention Type
Behavioral
Intervention Name(s)
health coaching
Intervention Description
Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set.
Intervention Type
Behavioral
Intervention Name(s)
community screening
Intervention Description
Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc.
Primary Outcome Measure Information:
Title
Change in Adult Body Mass Index
Time Frame
12 months
Title
Change in adult - physical activity
Time Frame
12 months
Title
Change in target child - Family Nutrition and Physical Activity Scale
Time Frame
12 months
Title
Change in target child - physical activity
Time Frame
12 months
Secondary Outcome Measure Information:
Title
adult - dietary intake
Time Frame
12 months
Title
adult - Physical activity questionnaires:
Time Frame
12 month
Title
adult - Waist Circumference:
Time Frame
12 months
Title
child - BMI z-score:
Time Frame
12 months
Title
child - Screen time questionnaire:
Time Frame
12 months
Title
child-Dietary measures:
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
obese adults or index 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
no data will be collected from nonindex children who meet the exclusion criteria.
obese adults who are currently pregnant at baseline will be excluded because of their altered weight and dietary patterns. If the obese adult 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 obese adult (see above).
weight, height, waist circumference and bioelectrical impedance will not be collected on pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
helena Laroche, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Health Care, Inc
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
DMARC food pantries
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigator will contact PI to discuss their interest in using the data to learn about what is available - data dictionary (code book) of variable names may be made available. Investigator must complete a form outlining what analysis they are proposing. Investigator must sign a confidentiality agreement. Data provided in de-identified format and must be destroyed after analysis and publication is complete.
IPD Sharing Time Frame
Available after 18-month data has been processed and cleaned. Estimated date: June 2020 (subject to change, dependent on COVID-19).
IPD Sharing Access Criteria
Form will be reviewed by the PI, UI investigative team and the community advisory board and a decision about approval will be made. A UI research team member must be included in the analysis team to help with context and interpretation of data.
Learn more about this trial
Family Obesity Intervention: Motivational Interviewing and Community Support
We'll reach out to this number within 24 hrs