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

NCT05324969 | Unknown DMC

• 1 other identifier: STUDY00006180
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Parents' Healthy Eating Index (HEI) converted from ASA24

  Automated Self-Administered 24-Hour Dietary Assessment (ASA24 2020) tool at NIH

  changes from baseline to post intervention about 4-6 months after baseline

Secondary Outcomes (12)

• Optional Hair Cortisol (dyads)

  change from baseline to post intervention, about 4-6 months after baseline assessment.

• Parents' Physical Activity

  change from baseline to post intervention, about 4-6 months after baseline assessment.

• health literacy (parent only)

  change from baseline to post intervention, about 4-6 months after baseline assessment.

• Kids' food screeners (parents reporting kids' eating pattern)

  change from baseline to post intervention, about 4-6 months after baseline assessment.

• Child's Physical Activity

  change from baseline to post intervention, about 4-6 months after baseline assessment.

Study Arms (2)

MM-based MI group

EXPERIMENTAL

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.

Behavioral: MM-based MI

Control group

OTHER

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.

Other: healthy education

Interventions

MM-based MI 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.

MM-based MI group

healthy education OTHER

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

Control group

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

Related Publications (1)

• 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.

  PMID: 39777051 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tsui-Sui A Kao, PhD

  MSU College of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: No marking intended given low budget and fewer research assistants available.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 13, 2022
• Study Start: February 8, 2022
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)