Overweight and ObesityMHFprojectNCT05324969
The Feasibility and Preliminary Efficacy of the Mindful-Healthy Family Intervention With Rural Families
A study testing MM-based MI and healthy education in people with Overweight and Obesity, run by Michigan State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- MM-based MI and healthy education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3-11 years old and one of his/her parents 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
Who cannot join
- excluding participants who are pregnant at baseline.
- exclude mentally and/or physically disabled person.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
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.
Read the detailed description
The RCT aims to enroll 34-60 dyads 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
- Being tested
- MM-based MI, healthy education
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MM-based MIBehavioural
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.
healthy educationOther
9 health education emails will be sent to participating parents in the control group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: healthy education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Eating Index (HEI) for Parent
The Healthy Eating Index (HEI) score derived from ASA24 reflects how closely an individual's reported food and beverage intake aligns with the Dietary Guidelines for Americans, summarizing overall diet quality on a scale from 1 to 100, with higher scores indicating healthier eating patterns.
Measured: baseline to post-intervention, approximately 4-6 months after baseline
Secondary outcomes (12)
Parents' Physical Activity
The International Physical Activity Questionnaire (IPAQ) total score is expressed in MET-minutes per week, with higher scores indicating greater levels of physical activity. Scores can range from 0 (no reported physical activity) to several thousand MET-minutes per week, depending on the frequency, duration, and intensity of activities performed.
Measured: change from baseline to post intervention, about 4-6 months after baseline assessment.
Health Literacy (Parent Only)
Health literacy (parent only) was assessed using the Newest Vital Sign (NVS), a validated screening tool that evaluates an individual's ability to read and apply health-related information. The NVS is based on interpretation of a nutrition label and yields a score ranging from 0 to 6, with higher scores indicating greater health literacy. Scores of 0-1 suggest a high likelihood of limited literacy, 2-3 indicate the possibility of limited literacy, and 4-6 reflect adequate health literacy.
Measured: change from baseline to post intervention, about 4-6 months after baseline assessment.
Total Daily Energy Intake (kcal)
Total daily energy intake (parent report) was estimated using the Block Dietary Screener, a validated food frequency questionnaire that assesses usual dietary intake over a specified period. Responses are used to estimate average daily energy intake (kilocalories per day) based on standardized nutrient databases and scoring algorithms. Higher values indicate greater total energy intake.
Measured: change from baseline to post intervention, about 4-6 months after baseline assessment.
Child's Physical Activity
Child physical activity (parent report) was assessed by the number of days in the past week that the child engaged adequately in physical activity. Parents reported the frequency of activity over the previous 7 days, yielding a score ranging from 0 to 7 days, with higher values indicating more frequent physical activity.
Measured: change from baseline to post intervention, about 4-6 months after baseline assessment.
Self-efficacy for Exercise (Parents)
Exercise self-efficacy was assessed using a 9-item self-reported measure evaluating confidence in the ability to engage in physical activity. Each item is scored on a scale from 0 ("Not confident") to 10 ("Very confident"). Item scores are summed to produce a total score ranging from 0 to 90, with higher scores indicating greater exercise self-efficacy.
Measured: change from baseline to post intervention, about 4-6 months after baseline assessment.
Collective Family Efficacy (Parents)
Collective family efficacy was assessed using a 20-item self-reported scale. Each item is rated on a 7-point Likert scale, and item scores are summed to yield a total score ranging from 20 to 140. Higher scores indicate greater levels of collective family efficacy.
Measured: change from baseline to post intervention, about 4-6 months after baseline assessment.
Centre for Epidemiological Studies Depression Scale (CES-D10)
Parental depressive symptoms were assessed using the 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10). Each item is rated on a 4-point scale ranging from "Rarely or none of the time" to "All of the time." Item scores are summed to yield a total score ranging from 0 to 30, with higher scores indicating greater depressive symptoms.
Measured: change from baseline to post intervention, about 4-6 months after baseline assessment.
Parents' Perceived Stress
Perceived stress (parent report) was assessed using the 10-item Perceived Stress Scale (PSS-10), which evaluates the degree to which situations in one's life are appraised as stressful. Items are rated on a 5-point Likert scale ranging from 0 ("Never") to 4 ("Very Often"). Four positively worded items (items 4, 5, 7, and 8) are reverse-scored prior to summation. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
Measured: change from baseline to post intervention, about 4-6 months after baseline assessment.
Parent's Family Function
Family functioning was assessed using a 5-item self-reported scale evaluating Adaptability, Partnership, Growth, Affection, and Resolve. Each item is scored on a 3-point scale (0 = "Hardly ever," 1 = "Some of the time," 2 = "Almost always"). Item scores are summed to yield a total score ranging from 0 to 10, with higher scores indicating greater satisfaction with family functioning across the five domains.
Measured: change from baseline parent's family function scores about 4-6 months after baseline assessment
Mindful Eating Questionnaire
Mindful eating (parent report) was assessed using a 28-item self-reported scale evaluating mindful eating attitudes across multiple domains (e.g., awareness, distraction, disinhibition, emotional, and external eating). Each item is rated on a 4-point scale. Domain scores are calculated by summing items within each domain and dividing by the number of items in that domain, yielding mean domain scores. A total summed score ranges from 28 to 112, with higher scores indicating greater levels of mindful eating.
Measured: change from baseline parent's mindful eating scores at 4 -6 months after baseline assessment.
Parent BMI
Parent body mass index (BMI) was calculated as weight in kilograms divided by height in meters squared (kg/m²). Higher BMI values indicate greater body weight relative to height.
Measured: change from baseline BMI at 4 -6 months after baseline assessment.
Hair Cortisol Concentration Level
Hair cortisol concentration was measured as a biomarker of chronic physiological stress. A small sample of hair was collected and analyzed to estimate cumulative cortisol exposure over time. Results are expressed as cortisol concentration (e.g., pg/mg of hair), with higher values indicating greater chronic stress levels.
Measured: from baseline to post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start8 Feb 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsui-Sui A Kao, Michigan State University
- Investigators
- Tsui-Sui A Kao, PhD, Principal investigator, MSU College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324969
- Sponsor's protocol ID
- STUDY00006180
- Acronym
- MHFproject
- Status last verified
- May 2026
- First submitted
- 14 Mar 2022
- Last updated
- 6 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: in our approved IRB application, there is no plan to make IPD available to other researchers.
Publications
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.
PubMed 39777051
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Preliminary Efficacy of the Mindful-Healthy Family Intervention With Rural Families
- ClinicalTrials.gov ID
- NCT05324969
- Acronym / sponsor ID
- MHFproject / STUDY00006180
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Posted 6 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 dyads 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MM-based MI group | Experimental | Behavioral: MM-based MIIntervention 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 | Other | Other: healthy educationControl 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. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3-11 years old and one of his/her parents 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
Key exclusion criteria (2 listed)
- excluding participants who are pregnant at baseline.
- exclude mentally and/or physically disabled person.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MM-based MI9 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. | Behavioural | MM-based MI group |
| healthy education9 health education emails will be sent to participating parents in the control group | Other | Control group |
Primary outcome
Healthy Eating Index (HEI) for Parent
Time frame: baseline to post-intervention, approximately 4-6 months after baseline
The Healthy Eating Index (HEI) score derived from ASA24 reflects how closely an individual's reported food and beverage intake aligns with the Dietary Guidelines for Americans, summarizing overall diet quality on a scale from 1 to 100, with higher scores indicating healthier eating patterns.
12 secondary outcomes
Parents' Physical Activity
Time frame: change from baseline to post intervention, about 4-6 months after baseline assessment.
Health Literacy (Parent Only)
Time frame: change from baseline to post intervention, about 4-6 months after baseline assessment.
Total Daily Energy Intake (kcal)
Time frame: change from baseline to post intervention, about 4-6 months after baseline assessment.
Child's Physical Activity
Time frame: change from baseline to post intervention, about 4-6 months after baseline assessment.
Self-efficacy for Exercise (Parents)
Time frame: change from baseline to post intervention, about 4-6 months after baseline assessment.
Collective Family Efficacy (Parents)
Time frame: change from baseline to post intervention, about 4-6 months after baseline assessment.
Centre for Epidemiological Studies Depression Scale (CES-D10)
Time frame: change from baseline to post intervention, about 4-6 months after baseline assessment.
Parents' Perceived Stress
Time frame: change from baseline to post intervention, about 4-6 months after baseline assessment.
Parent's Family Function
Time frame: change from baseline parent's family function scores about 4-6 months after baseline assessment
Mindful Eating Questionnaire
Time frame: change from baseline parent's mindful eating scores at 4 -6 months after baseline assessment.
Parent BMI
Time frame: change from baseline BMI at 4 -6 months after baseline assessment.
Hair Cortisol Concentration Level
Time frame: from baseline to post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39777051Kao 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.
- Individual participant dataSharing planned: No. in our approved IRB application, there is no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsui-Sui A Kao, PhD principal investigator
MSU College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MM-based MI and healthy education in people with Overweight and Obesity, run by Michigan State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Eating Index (HEI) for Parent (time frame: baseline to post-intervention, approximately 4-6 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05324969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.