Clinical trial NCT05324969: The Feasibility and Preliminary Efficacy of the Mindful-Healthy Family Intervention With Rural Families
Official title: The Feasibility and Preliminary Efficacy of the Mindful-Healthy Family Intervention With Rural Families
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 49
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group will receive 9 intervention sessions (via zoom or phone call) every other week and 3 texts/week to motivate lifestyle changes. Three times of rescheduling is allowed. Attention control group will receive 9 biweekly emails about other health related topics.
Primary purpose: PREVENTION

Brief summary: This two-group RCT, the Mindful-Healthy Family project, will test the feasibility and preliminary efficacy of a mindfulness-based Motivational Interviewing (MM-based-MI) intervention with rural families within Michigan. This two-group RCT will enroll 34-60 families from Michigan rural or suburban communities with one OW/O parent-figure adult (BMI ≥25) who has at least one child (ages 3-6) at home. The targeted parents will serve as the change agent. The outcome assessments include BMI and optional hair cortisol as well as parent's collective family efficacy, perceived stress, depression score, 24 hours dietary recall (ASA24; healthy eating index \[HEI\]), mindful eating score, Physical Activity (IPAQ-short) at both baseline and post-intervention. These intervention group families will receive 9 online sessions (30 min/session) delivered via Zoom or phone calls every other week by trained research staff. BMI will be obtained directly from the participating parents using the scale delivered to their homes. Attention control arm families will have same assessment and will receive a total of 9 mailed packets of educational materials. This work will advance the science by explicating how MM and MI work synergistically.

Detailed description: The RCT aims to enroll 34-60 families from Michigan rural or suburban communities. Because the investigators are targeting overweight or obese parents (BMI greater than 25 but less than 45),the investigators anticipate excluding some ineligible families. The investigators plan to use the rolling admission strategy to obtain eligible families. With our inclusion/exclusion criteria, the investigators estimate the needs to approach approximately 80-300 parents. To begin, the investigators will start the eligibility screening and recruitment procedure with local community recruiters from willing clinics, rural communities as well as online advertisements. If the investigators do not have a sufficient sample by the end of two months, the investigators will proceed to recruit families from rural communities to suburban communities via Craigslist advertisements and other online platforms. The investigators will use our previous experience with the rural communities to determine strategies needed to proceed with our recruitment effort.

In fall 2022, The investigators will hire 2-3 part-time staffs from the Tribal communities to assist us with recruitment efforts with American Indian families. The investigators would also use snowball any eligible families identified by our enrolled families. This local part-time staff will distribute recruitment flyer to adjunct American Indian communities. Potential participants can complete eligibility screening either by a self-administered online survey (Qualtrics) or by direct interactions with research staff (either in-person or telephone calls).

Intervention Procedure:

The outcome assessments (BMI and optional hair cortisol assessments) as well as surveys (ASA24 and Qualtrics) will be collected remotely. The RA will call the participating families and guide assessment step by step using the measurement tool sent to their homes. Once enrolled, participating families will be randomized into two groups (1.5 to 1 ratio): intervention and control group.

Intervention group parents will also receive nine intervention sessions every other week by trained research staff. The investigators will deliver the intervention via 9 online sessions delivered via Zoom or phone calls. Each intervention session will last about 30-40 minutes. Interventional group parents will receive 3 text messages (or emails, per preference) per week to improve their motivation to lead a mindful and healthy lifestyle (eating, physical activity, and positive family interactions). No in-person contacts will be conducted without MSU department permission. The assessment of dyads' BMI will be obtained directly and remotely from the participating parents using the scale and measuring tape delivered to their homes. Hair cortisol assessment is optional for the participants. If willing, the participants will receive a hair sample collection video as well as written instruction. A step-by step assistance (via phone call or zoom) will be available for participants. Control group parents will receive a total of 9 emailed packets of educational materials (without information related to the mindfulness-based motivational interviewing \[MM-based-MI\]). Assessment procedure remains the same for both groups.

Eligibility criteria: Inclusion Criteria:

* Children aged 3-11 years old and one of his/her parent whose BMI \>25 but less than 45.
* Both parent and child are required to enroll together
* Parent and child are willing to do height and weight assessment (using the scale and wall growth chart mailed to home) and some surveys (parents only) remotely

Exclusion Criteria:

* excluding participants who are pregnant at baseline.
* exclude mentally and/or physically disabled person.

Primary outcomes:
measure: Parents' Healthy Eating Index (HEI) converted from ASA24
timeFrame: changes from baseline to post intervention about 4-6 months after baseline
Secondary outcomes:
measure: Optional Hair Cortisol (dyads)
timeFrame: change from baseline to post intervention, about 4-6 months after baseline assessment.
measure: Parents' Physical Activity
timeFrame: change from baseline to post intervention, about 4-6 months after baseline assessment.
measure: health literacy (parent only)
timeFrame: change from baseline to post intervention, about 4-6 months after baseline assessment.
measure: Kids' food screeners (parents reporting kids' eating pattern)
timeFrame: change from baseline to post intervention, about 4-6 months after baseline assessment.
measure: Child's Physical Activity
timeFrame: change from baseline to post intervention, about 4-6 months after baseline assessment.
measure: Self-efficacy for Exercise (parents)
timeFrame: change from baseline to post intervention, about 4-6 months after baseline assessment.
measure: Collective family efficacy (parents)
timeFrame: change from baseline to post intervention, about 4-6 months after baseline assessment.
measure: Centre for Epidemiological Studies Depression Scale (CES-D10)
timeFrame: change from baseline to post intervention, about 4-6 months after baseline assessment.
measure: Parents' perceived stress
timeFrame: change from baseline to post intervention, about 4-6 months after baseline assessment.
measure: Parent's family function
timeFrame: change from baseline parent's family function scores about 4-6 months after baseline assessment
measure: Mindful eating questionnaire
timeFrame: change from baseline parent's mindful eating scores at 4 -6 months after baseline assessment.
measure: Parent BMI
timeFrame: change from baseline BMI at 4 -6 months after baseline assessment.
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: MSU College of Nursing
name: Tsui-Sui A Kao, PhD
role: PRINCIPAL_INVESTIGATOR
References: