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临床试验/NCT05324969
NCT05324969进行中(未招募)不适用

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

Michigan State University2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2022年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
49
试验地点
2
主要终点
Parents' Healthy Eating Index (HEI) converted from ASA24

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

No marking intended given low budget and fewer research assistants available.

入排标准

年龄范围
3 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 3-11 years old and one of his/her parent whose BMI >25 but less than
  • 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

排除标准

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

研究组 & 干预措施

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.

干预措施: healthy education (Other)

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.

干预措施: MM-based MI (Behavioral)

结局指标

主要结局

Parents' Healthy Eating Index (HEI) converted from ASA24

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

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

次要结局

  • 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.)
  • Optional Hair Cortisol (dyads)(change from baseline to post intervention, about 4-6 months after baseline assessment.)
  • Centre for Epidemiological Studies Depression Scale (CES-D10)(change from baseline to post intervention, about 4-6 months after baseline assessment.)
  • Parent BMI(change from baseline BMI at 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.)
  • Self-efficacy for Exercise (parents)(change from baseline to post intervention, about 4-6 months after baseline assessment.)
  • Collective family efficacy (parents)(change from baseline to post intervention, about 4-6 months after baseline assessment.)
  • Parent's family function(change from baseline parent's family function scores about 4-6 months after baseline assessment)
  • Mindful eating questionnaire(change from baseline parent's mindful eating scores at 4 -6 months after baseline assessment.)
  • Child's Physical Activity(change from baseline to post intervention, about 4-6 months after baseline assessment.)
  • Parents' perceived stress(change from baseline to post intervention, about 4-6 months after baseline assessment.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tsui-Sui A Kao

Associate Professor

Michigan State University

研究点 (2)

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