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- Klinische proef NCT05324969
De haalbaarheid en voorlopige doeltreffendheid van de Mindful-Healthy Family Interventie bij plattelandsgezinnen (MHFproject)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Michigan
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East Lansing, Michigan, Verenigde Staten, 48824
- Michigan State University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- excluding participants who are pregnant at baseline.
- exclude mentally and/or physically disabled person.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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. |
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. |
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Ander: 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. |
9 health education emails will be sent to participating parents in the control group |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Healthy Eating Index (HEI) for Parent
Tijdsspanne: baseline to post-intervention, approximately 4-6 months after baseline
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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. |
baseline to post-intervention, approximately 4-6 months after baseline
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Parents' Physical Activity
Tijdsspanne: change from baseline to post intervention, about 4-6 months after baseline assessment.
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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. |
change from baseline to post intervention, about 4-6 months after baseline assessment.
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Health Literacy (Parent Only)
Tijdsspanne: change from baseline to post intervention, about 4-6 months after baseline assessment.
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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. |
change from baseline to post intervention, about 4-6 months after baseline assessment.
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Total Daily Energy Intake (kcal)
Tijdsspanne: change from baseline to post intervention, about 4-6 months after baseline assessment.
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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. |
change from baseline to post intervention, about 4-6 months after baseline assessment.
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Child's Physical Activity
Tijdsspanne: change from baseline to post intervention, about 4-6 months after baseline assessment.
|
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. |
change from baseline to post intervention, about 4-6 months after baseline assessment.
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Self-efficacy for Exercise (Parents)
Tijdsspanne: change from baseline to post intervention, about 4-6 months after baseline assessment.
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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. |
change from baseline to post intervention, about 4-6 months after baseline assessment.
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Collective Family Efficacy (Parents)
Tijdsspanne: change from baseline to post intervention, about 4-6 months after baseline assessment.
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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. |
change from baseline to post intervention, about 4-6 months after baseline assessment.
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Centre for Epidemiological Studies Depression Scale (CES-D10)
Tijdsspanne: change from baseline to post intervention, about 4-6 months after baseline assessment.
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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. |
change from baseline to post intervention, about 4-6 months after baseline assessment.
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Parents' Perceived Stress
Tijdsspanne: change from baseline to post intervention, about 4-6 months after baseline assessment.
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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. |
change from baseline to post intervention, about 4-6 months after baseline assessment.
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Parent's Family Function
Tijdsspanne: change from baseline parent's family function scores about 4-6 months after baseline assessment
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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. |
change from baseline parent's family function scores about 4-6 months after baseline assessment
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Mindful Eating Questionnaire
Tijdsspanne: change from baseline parent's mindful eating scores at 4 -6 months after baseline assessment.
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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. |
change from baseline parent's mindful eating scores at 4 -6 months after baseline assessment.
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Parent BMI
Tijdsspanne: change from baseline BMI at 4 -6 months after baseline assessment.
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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. |
change from baseline BMI at 4 -6 months after baseline assessment.
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Hair Cortisol Concentration Level
Tijdsspanne: from baseline to post-intervention
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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. |
from baseline to post-intervention
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Tsui-Sui A Kao, PhD, MSU College of Nursing
Publicaties en nuttige links
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Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- STUDY00006180
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
in our approved IRB application, there is no plan to make IPD available to other researchers.
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