search
Back to results

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

Primary Purpose

Overweight and Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MM-based MI
healthy education
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children aged 3-6 years old and one of his/her parent whose BMI >25 but less than 45.
  • Both parent and child are required to enroll together

Exclusion Criteria:

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

Sites / Locations

  • Michigan State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MM-based MI group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

BMI
Body Mass Index

Secondary Outcome Measures

%BF
Percent Body fat
WC (dyads)
Waist Circumference
Optional Hair Cortisol (dyads)
Hair Cortisol (optional and only when in-person assessment is allowed)
Parents' Eating patterns
Automated Self-Administered 24-Hour Dietary Assessment (ASA24 2020) tool at NIH
Parents' Physical Activity
self-reported Physical Activity (PA) using the International Physical Activity Questionnaire (IPAQ). The minimal score is 0 and the maximal score is 4,000 MET-minutes. A higher score represents a higher intensity of physical activity.
health literacy (parent only)
using the Newest Vital Sign to assess parents' healthy literacy
Kids' food screeners (parents reporting kids' eating pattern)
Block Kids food screeners to assess kids' eating patterns
Child's Physical Activity
This is one item survey assessing the children's Physical Activity in the past 7 day. The minimal score is 0 day and the maximal score is 7 days/week. A higher score represents a higher number of days in the past week that the child spent at least 60 minutes a day.
Self-efficacy for Exercise (parents)
This is 9-item self-reported self-efficacy measure. A 10-item perceived stress scale (0-4 Likert scale). The minimal score is 0 and the maximal score is 40. A higher score represents a higher level of perceived stress.
Collective family efficacy (parents)
This is a 20-item collective family efficacy scale (1-7-point Likert scale). The minimal score is 20, and the maximal score is 140. A higher score represents a higher level of collective family efficacy.
Centre for Epidemiological Studies Depression Scale (CES-D10)
Centre for Epidemiological Studies Depression Scale (CES-D 10) will be used to assess parents' depression symptoms. This is a 10-item depression symptom scale. The minimal score is 0, and the maximal score is 30. A higher score represents greater depressive symptoms.
Parents' perceived stress
This is a 10-item perceived stress scale will be used to assess parents' perceived stress level. The minimal score is 0, and the maximal score is 60. A higher score represents greater depressive symptoms.
Parent's family function
This is a 5-item family function scale assessing family member's Adaptability, Partnership, Growth, Affection, and Resolve. The minimal score is 0, and the maximal score is 10. A higher score represents a greater satisfaction of family functioning in above five domains.
Mindful eating questionnaire
This is a 28-item 1-4-point scale assessing parent's mindful eating attitudes in four domains (awareness, distraction, disinhibition, emotional, external). The subsumed score will be divided by the item number allocated in each domain. The minimal score is 1, and the maximal score is 4. A higher score represents a higher level of mindful eating in each domain.

Full Information

First Posted
March 14, 2022
Last Updated
August 22, 2022
Sponsor
Michigan State University
search

1. Study Identification

Unique Protocol Identification Number
NCT05324969
Brief Title
The Feasibility and Preliminary Efficacy of the Mindful-Healthy Family Intervention With Rural Families
Acronym
MHFproject
Official Title
The Feasibility and Preliminary Efficacy of the Mindful-Healthy Family Intervention With Rural Families
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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, %BF, WC, BP, and optional hair cortisol 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, %BF, and WC will be obtained directly from the participating parents using the scale delivered to their homes. 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. More specifically, the investigators would preferably hire a part-time staff associated with the Inter-Tribal Council of Michigan (ITCM) to facilitate our recruitment with American Indian families. With assistance of these 2-3 part-time staff, the investigators will send prescreening QR code and recruitment flyers to all potential eligible 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, %BF, WC, and optional hair cortisol assessments) 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 (2 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, %BF, and WC 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
intervention group will receive 9 biweekly intervention sessions (via zoom or phone call) and 3 texts/week to motivate lifestyle changes. Control group will receive 9 biweekly emails about other health related topics.
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MM-based MI group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MM-based MI
Intervention Description
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
Other
Intervention Name(s)
healthy education
Intervention Description
9 health education emails will be sent to participating parents in the control group
Primary Outcome Measure Information:
Title
BMI
Description
Body Mass Index
Time Frame
change from baseline BMI at 4 months
Secondary Outcome Measure Information:
Title
%BF
Description
Percent Body fat
Time Frame
change from baseline percent body fat at 4 months
Title
WC (dyads)
Description
Waist Circumference
Time Frame
change from baseline WC at 4 months
Title
Optional Hair Cortisol (dyads)
Description
Hair Cortisol (optional and only when in-person assessment is allowed)
Time Frame
change from baseline hair cortisol at 4 months
Title
Parents' Eating patterns
Description
Automated Self-Administered 24-Hour Dietary Assessment (ASA24 2020) tool at NIH
Time Frame
change from baseline eating patterns at 4 months
Title
Parents' Physical Activity
Description
self-reported Physical Activity (PA) using the International Physical Activity Questionnaire (IPAQ). The minimal score is 0 and the maximal score is 4,000 MET-minutes. A higher score represents a higher intensity of physical activity.
Time Frame
change from baseline parent's PA at 4 months
Title
health literacy (parent only)
Description
using the Newest Vital Sign to assess parents' healthy literacy
Time Frame
change from baseline health literacy at 4 months
Title
Kids' food screeners (parents reporting kids' eating pattern)
Description
Block Kids food screeners to assess kids' eating patterns
Time Frame
change from baseline kids' eating patterns at 4 months
Title
Child's Physical Activity
Description
This is one item survey assessing the children's Physical Activity in the past 7 day. The minimal score is 0 day and the maximal score is 7 days/week. A higher score represents a higher number of days in the past week that the child spent at least 60 minutes a day.
Time Frame
change from baseline child's PA at 4 months
Title
Self-efficacy for Exercise (parents)
Description
This is 9-item self-reported self-efficacy measure. A 10-item perceived stress scale (0-4 Likert scale). The minimal score is 0 and the maximal score is 40. A higher score represents a higher level of perceived stress.
Time Frame
change from baseline parent's efficacy scores at 4 months
Title
Collective family efficacy (parents)
Description
This is a 20-item collective family efficacy scale (1-7-point Likert scale). The minimal score is 20, and the maximal score is 140. A higher score represents a higher level of collective family efficacy.
Time Frame
change from baseline parent's collective efficacy scores at 4 months
Title
Centre for Epidemiological Studies Depression Scale (CES-D10)
Description
Centre for Epidemiological Studies Depression Scale (CES-D 10) will be used to assess parents' depression symptoms. This is a 10-item depression symptom scale. The minimal score is 0, and the maximal score is 30. A higher score represents greater depressive symptoms.
Time Frame
change from baseline parent's depression symptoms at 4 months
Title
Parents' perceived stress
Description
This is a 10-item perceived stress scale will be used to assess parents' perceived stress level. The minimal score is 0, and the maximal score is 60. A higher score represents greater depressive symptoms.
Time Frame
change from baseline parent's perceived stress scores at 4 months
Title
Parent's family function
Description
This is a 5-item family function scale assessing family member's Adaptability, Partnership, Growth, Affection, and Resolve. The minimal score is 0, and the maximal score is 10. A higher score represents a greater satisfaction of family functioning in above five domains.
Time Frame
change from baseline parent's family function scores at 4 months
Title
Mindful eating questionnaire
Description
This is a 28-item 1-4-point scale assessing parent's mindful eating attitudes in four domains (awareness, distraction, disinhibition, emotional, external). The subsumed score will be divided by the item number allocated in each domain. The minimal score is 1, and the maximal score is 4. A higher score represents a higher level of mindful eating in each domain.
Time Frame
change from baseline parent's mindful eating scores at 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged 3-6 years old and one of his/her parent whose BMI >25 but less than 45. Both parent and child are required to enroll together Exclusion Criteria: excluding participants who are pregnant at baseline. exclude mentally and/or physically disabled person.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MSU College of Nursing
Phone
517-355-2180
Email
irb@msu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tsui-Sui A Kao, PhD
Phone
517-353-8681
Email
kaotsuis@msu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsui-Sui A Kao, PhD
Organizational Affiliation
MSU College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsui-Sui A Kao, PhD
Phone
517-353-8681
Email
kaotsuis@msu.edu
First Name & Middle Initial & Last Name & Degree
Jiying Ling, PhD
Phone
517-353-8591
Email
lingjiyi@msu.edu
First Name & Middle Initial & Last Name & Degree
Tsui-Sui Kao, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
in our approved IRB application, there is no plan to make IPD available to other researchers.

Learn more about this trial

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

We'll reach out to this number within 24 hrs