The Feasibility and Preliminary Efficacy of the Mindful-Healthy Family Intervention With Rural Families

NCT ID: NCT05324969

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-08
• Study Completion Date: 2024-08-01

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.

Conditions

Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

MM-based MI group

Intervention group parents will receive 9 intervention sessions every other week by trained staff via 9 online sessions via Zoom or phone calls. Each intervention session will last 30-40 minutes. Intervention group parents will receive 3 text messages per week. No in-person contacts will be conducted without MSU department permission. All assessments will be delivered remotely with guided phone calls or zoom conference. The assessment of dyads' BMI, %BF, and WC will be obtained remotely from the parents using the scale and measuring tape delivered to their home.

Group Type: EXPERIMENTAL

MM-based MI

Intervention Type: BEHAVIORAL

9 remote mindful-based MI sessions will be delivered to promote participating parents' mindful eating, mindful movements, and mindful family interactions. Parents will be encouraged to act as changing agents for their families.

Control group

Control group parents will receive a total of 9 emailed packets of educational materials (without information related to the mindfulness-based motivational interviewing \[MM-based-MI\]). The pre and post assessments will be collected the same way as the participants at intervention group.

Group Type: OTHER

healthy education

Intervention Type: OTHER

9 health education emails will be sent to participating parents in the control group

Interventions

MM-based MI

9 remote mindful-based MI sessions will be delivered to promote participating parents' mindful eating, mindful movements, and mindful family interactions. Parents will be encouraged to act as changing agents for their families.

Intervention Type: BEHAVIORAL

healthy education

9 health education emails will be sent to participating parents in the control group

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Tsui-Sui A Kao

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tsui-Sui A Kao, PhD

Role: PRINCIPAL_INVESTIGATOR

MSU College of Nursing

Locations

Michigan State University

East Lansing, Michigan, United States

Countries

United States

References

Kao TA, Ling J, Alanazi M, Bara N, Barnes Najor J. Feasibility and preliminary effects of the mindful healthy family project among rural families. Health Psychol Behav Med. 2024 Dec 26;13(1):2446368. doi: 10.1080/21642850.2024.2446368. eCollection 2025.

Reference Type: DERIVED

PMID: 39777051 (View on PubMed)

Other Identifiers

STUDY00006180

Identifier Type: -

Identifier Source: org_study_id