Clinical trial NCT02669797: Family Matters Intervention
Official title: Reducing Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback at Family Meals
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Childhood Obesity
Cardiovascular Disease Prevention
Keywords: Childhood Obesity
Ecological Momentary Intervention
Video Feedback
Cardiovascular Disease
Cardiovascular Health
Community Health Worker
Home Visiting
Virtual
Hybrid
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-02-01
Enrollment: 500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-arm, individual randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: The proposed study is a 12-month, individual randomized controlled trial (RCT). The main aim of the study is to decrease cardiovascular disease risk (BMI percentile, neck circumference) and improve child diet quality in children ages 5-10 years old by increasing family meal quality (i.e., dietary intake, interpersonal atmosphere) and quantity (i.e., frequency of family meals) via innovative technology (i.e., ecological momentary intervention (EMI), video feedback) and partnerships with primary care and Community Health Workers (CHWs).

Detailed description: The RCT has the following three arms: (1) Ecological Momentary Intervention (EMI); (2) EMI + HV + Video feedback (virtual); (3) EMI + HV + Video feedback (hybrid). Delivery of the intervention will last 6 months for each family, with a 6-month post-intervention evaluation visit. All arms will receive EMI family meal tips via smartphones for 16 weeks. Arms 2 and 3 will also receive 16 weeks of in-home training (arm 2 will be virtual, arm 3 will be hybrid virtual/in-home), with 8 weeks (every other week) in-home education visits with a CHW focused on family meal quality and quantity and a family meal preparation activity and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW. Additionally, Arms 2 and 3 will receive video feedback from family's video-recorded family meals by a CHW focusing on family behaviors related to family meal quality and quantity. (EMI, in-home training, and video-feedback will occur during the same 16-week period.) After families have completed 16 weeks of the intervention, a 8-week maintenance phase will ensue. Having a maintenance phase is an evidence-based intervention component and will provide incrementally less support to families to build self-efficacy and increase sustainability of new behaviors. Over time, participants will receive less study support to evaluate if participants have internalized healthful behaviors. During the maintenance phase EMI meal tips will be reduced to only the days in which parents report their highest stress levels for all arms. The study will last 12 months, with three assessment time points including, baseline, 6 months (i.e., post-intervention) and 12 months.

Children ages 5-10 and family members (i.e., parent/primary caregiver, siblings) from low-income and diverse households (i.e., African American, Asian, Hispanic, Native American, White) - who are at high risk for cardiovascular disease - will be recruited for the study. Theory informs the intervention study design, research questions and related hypotheses, methods, measurement, and analysis. Family Systems Theory drives the decision to direct the intervention at the "family unit" to increase the likelihood of individual and family-level weight and weight-related behavior change and sustainability. Additionally, partnerships with existing community-based healthcare systems and CHWs will be utilized to reach participants in community settings.

This study utilizes innovative and research-informed intervention components (i.e., in-home visiting, EMI, video-feedback) to increase the likelihood of intervention effectiveness and sustainability. The "Family Matters" study will be carried out across two Phases, an R61 Phase and an R33 Phase. Specific aims for each Phase are described below:

Specific Aims for the R61 Phase:

• Aim 1 (Primary Outcomes): Conduct a three-arm RCT comparing EMI, EMI+HV, and EMI+HV+Video Feedback in diverse children ages 5-10 and their families to test the hypotheses that:

Hypothesis 1: BMI percentile and neck circumference will decrease and diet quality will increase in children in the EMI+HV+Video Feedback hybrid arm compared to children in the EMI or virtual-only arms.

• Aim 2 (Secondary Outcomes): Examine intervention effects on familial, parental, and sibling factors.

Hypothesis 1: Family meal quality and quantity will increase in households with children in the EMI+HV+ Video Feedback hybrid arm compared to children in the EMI or virtual arms.

Hypothesis 2: Controlling feeding practices (e.g., restriction) will decrease and coping skills will increase in parents in the EMI+HV+Video Feedback hybrid arm compared to parents in the EMI or virtual arms.

Hypothesis 3: BMI percentile will decrease in siblings in the EMI+HV+Video Feedback hybrid arm compared to siblings in the EMI or virtual arms.

• Aim 3: Examine cost effectiveness and feasibility of intervention implementation in primary care.

Hypothesis 1: The BMI z-score and neck circumference reduction resulting from the intervention will be cost-effective.

Eligibility criteria: STUDY INCLUSION CRITERIA

The inclusionary criteria used to select participants for the proposed study includes:

1. Boys and girls (n=500) ages 5-10 years old who attend a University of Minnesota Physicians (n=4) or Fairview (n=8) primary care clinic and their primary caregiver (e.g., mother, father, grandparent) and at least one sibling. A second primary caregiver and other family members can also participate.
2. Must eat ≤3 family dinner meals per week. Research shows that youth who have more than three family meals per week are less likely to be obese ten years later. Thus, families who report three or fewer family meals per week will be recruited to optimize the potential for change in family meal frequency. Families will focus on the family dinner in the intervention to improve their family meal quality and quantity. This decision is based on: (1) Family Systems Theory, which indicates that change in one setting (e.g., family dinner) will generalize to other settings (e.g., breakfast, lunch, snacks).
3. Child with age and sex adjusted BMI ≥75th percentile (no upper limit).
4. One of the following race/ethnicities: African American, Asian, Hispanic/Latino, Native American, Asian American, or White. In order to examine racial/ethnic differences in study hypotheses, equal numbers of children per racial/ethnic group (total=500) will be recruited.
5. Parent and family members who speak English or Spanish.
6. Not expected to move within the next two years.

STUDY EXCLUSION CRITERIA

The exclusionary criteria used to exclude participants from the proposed study includes:

1. Children with medically necessary dietary restrictions (reviewed by MD from primary care clinics).
2. Non-custodial parents, who the child does not live with more than 50% of the time.

Primary outcomes:
measure: Child BMI percentile
timeFrame: 12-months post-baseline
measure: Child Dietary Quality
timeFrame: 12-months post-baseline
measure: Child Neck Circumference
timeFrame: 12-months post-baseline
Secondary outcomes:
measure: Family Meal Quantity
timeFrame: 12-months post-baseline
measure: Family Meal Dietary Healthfulness
timeFrame: 12-months post-baseline
measure: Family Meal Emotional Atmosphere Quality
timeFrame: 12-months post-baseline
measure: Sibling BMI percentile
timeFrame: 12-months post-baseline
measure: Parent Feeding Practices
timeFrame: 12-months post-baseline
measure: Parent Coping Skills
timeFrame: 12-months post-baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Minneapolis
country: United States
facility: Department of Family Medicine and Community Health
state: Minnesota
Study officials:
References: