Family Matters Intervention: A Three-Arm Superiority RCT

The proposed study is an 18-month, individual randomized controlled superiority trial (RCT).
The main aim of the study is to decrease childhood obesity in children ages 5-7 years old by
increasing family meal quality (i.e., dietary intake, emotional atmosphere) and quantity
(i.e., frequency of family meals) via innovative technology (i.e., ecological momentary
intervention (EMI), video feedback). The RCT is a three-arm superiority trial including the
following three arms: (1) Education (Edu)+EMI; (2) Edu+EMI+Video feedback; and (3) Attention
Control. Delivery of the intervention will last 12 months for each family, which includes a
12-week maintenance phase. All three arms will receive primary care visits with 5-2-1-0
obesity prevention messages. The two experimental arms will additionally receive twelve
in-home training visits focused on family meal quality and quantity and then will receive
either EMI family meal tips via smartphones, or EMI family meal tips with video feedback. The
attention control group will receive messages on general child health delivered in a similar
manner and frequency as the experimental arms. After families have completed nine months of
the study, a maintenance phase will ensue for three months. Having a maintenance phase is
evidence-based and will provide incrementally less support to families to allow for
self-efficacy to increase and sustainability of new behaviors to occur. For study arms 1 and
2, EMI meal tips will be reduced to only the days in which parents report their highest
stress levels. For participants in study arm 2, video feedback will be reduced to once per
month. The attention control arm maintenance phase will include reductions in text messages
and video-recorded tips at a similar frequency as arms 1 and 2. The study will last 18
months, with four assessment time points including, baseline, 9 months, 12 months (i.e.,
post-intervention), and 18 months (i.e., 6-month post-intervention). The eligible child and
multiple family members (i.e., parent/primary caregiver, siblings) from low-income and
diverse households (i.e., African American, Hispanic, Native American, White)--who are at
greatest risk for obesity--will be recruited for the study. Additionally, partnerships with
existing community-based healthcare systems will be utilized to reach participants in
community settings where they have existing relationships and resources. 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 Intervention" study will be carried out across two Phases, an R61 Phase
and an R33 Phase. Main aims for each Phase are described below: Specific Aims for the R61
Phase: Aim 1: Organize and prepare the study team, project materials, study protocols and
procedures. Success of Aim 1 will be measured by meeting established R61 Planning Phase
transition milestones. Aim 2: Test recruitment, evaluation, and intervention protocols in the
first 24 (2 per race/ethnicity and study arm) eligible participants. Aim 2 success will be
achieved by meeting transition milestones related to screening, enrollment, assessment,
intervention delivery, and retention. Specific Aims for the R33 Phase: Aim 1: Conduct a
three-arm RCT comparing Education (Edu)+EMI, Education+EMI+video feedback, and attention
control arms in children ages 5-7 years old and their families to test the hypotheses that:
Hypothesis 1: Family meal quality and quantity will increase in households with children in
the Edu+EMI+ video feedback arm compared to children in the Edu+EMI or attention control
arms. Hypothesis 2: Diet quality will increase and BMI z-score/BMI percentile will decrease
in children in the Edu+EMI+video feedback arm compared to children in the Edu+EMI and
attention control arms; family meal quality and quantity will mediate this association. Aim
2: Examine intervention effects on parent and sibling weight and weight-related behaviors.
Hypothesis 1: Restriction and pressure-to-eat feeding practices will decrease and coping
skills will increase in parents in the Edu+EMI+video feedback arm compared to the Edu+EMI and
attention control arms. Hypothesis 2: BMI z-score/BMI percentile will decrease in siblings in
the EMI+video feedback arm compared to Edu+EMI and attention control arms.

STUDY INCLUSION CRITERIA

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

1. Boys and girls (n=376) ages 5-7 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 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 choose which meal (i.e.,
breakfast, lunch, dinner) they would like to focus on 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); (2) prior research showing that families
benefit from family meals eaten any time in the day (i.e., breakfast, lunch, dinner),
and (3) to allow flexibility for families' preferences and schedules.

3. Child with age and sex adjusted BMI ≥85th percentile (no upper limit).

4. One of the following race/ethnicities: African American, Hispanic/Latino, Native
American, or White. In order to examine racial/ethnic differences in study hypotheses,
94 children per racial/ethnic group (total=376) 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 special dietary, physical, or behavioral needs (reviewed by MD from
primary care clinics).

2. Non-custodial parents, who the child does not live with more than 50% of the time.