Mountain West Prevention Research Center Core Research Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Reach: Enrollment in the Building Healthy Families Program
研究概览
简要总结
This hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial will assess the impact of integrating population health management (PHM) strategies-text messaging and enrollment in Building Healthy Families (BHF)-for lower-income families with a child with obesity identified through electronic health record (EHR) data. BHF promotes family healthy eating, physical activity, and lifestyle behavior strategies to manage weight. The research team will partner with clinical sites (community health clinics, pediatric clinics, rural hospitals) and Community-Based Organizations (CBOs). Clinical partners will execute data-sharing agreements enabling the research team to identify eligible children and caregivers and conduct outreach via text messaging. CBO partners will deliver BHF and provide de-identified data for program evaluation. Community Implementation Teams (CITs) will complete training, surveys, interviews, learning collaborative activities, fidelity assessments, and time tracking as part of quality improvement. The BHF Action Learning Collaborative will use quarterly sessions and Plan-Do-Study-Act cycles to address recruitment, implementation, sustainability, social determinants of health, and team coordination. The research team will record sessions, conduct direct observations of BHF delivery, and take field notes to assess fidelity and adaptations. Families will be identified through EHR records and mailed a consent and authorization cover letter, postcard, QR code, and intervention information with opt-out options. Those who do not opt out will be randomized to bidirectional text messaging with one-touch response and enrollment opportunities, with or without active outreach (telephone or text) from the local CIT. Enrolled families will complete orientation, baseline assessment, and weekly group sessions with ongoing follow-up. Attendance, body weight, goals, and self-monitoring will be recorded in a CIT data portal. Families will be randomized to receive either simple text reminders or reminders with motivational and skill-building prompts matched to session topics. CITs will also connect families to food assistance programs and local resources. Each CIT will complete two cohorts over two years. The primary outcome is reach; secondary outcomes include session attendance, changes in child BMI-z scores, changes in parent or caregiver weight, and changes in adoption, implementation, and maintenance at the community level.
详细描述
The researchers propose a hybrid type 3 effectiveness-implementation sequential multiple assignment randomized trial (HEI-SMART) to determine the impact of integrating population health management (PHM) via text messaging and direct enrollment in Building Healthy Families (BHF) for lower-income families with a child aged 5-12 years with obesity identified through clinical partner (community health clinics, pediatric clinics, rural hospitals) electronic health record data. The sequential randomization design focuses on both initial recruitment (primary outcome) and retention in BHF sessions by randomly assigning enrolled families to text-only or text plus motivational retention messages.
BHF is a community-delivered evidence-based intervention to prevent and treat childhood obesity. The intervention educates families about healthy eating, physical activity, and healthy habits and facilitates goal setting and self-monitoring to improve lifestyle behaviors and manage weight. BHF includes a standard program evaluation conducted by community-based organizations (CBOs) to support quality improvement. The initial procedures describe activities undertaken by the research team to facilitate BHF delivery.
Identifying Community Partners An interdisciplinary network across the Mountain West region will provide infrastructure for applied research addressing obesity-related disparities among low-income families in rural and micropolitan communities in Idaho, Montana, Nevada, Utah, Wyoming, and surrounding states. This network will identify clinical organizations and CBOs to partner in identifying eligible patients and delivering BHF.
Clinical Organizations Participating clinical organizations will complete data-sharing agreements enabling PHM strategies to identify eligible children and caregivers through EHRs and conduct outreach via text messaging. Agreements permit study procedures to be conducted by the University of Utah research team, reducing burden on clinical partners.
The PHM strategy:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent or legal caregiver and at least one child aged 5 to 12 years
- •Child identified through electronic health record data from a participating clinical organization
- •Child has had at least one clinical encounter at the participating site within the past 12 months
- •Child has body mass index (BMI) at or above the 85th percentile for age and sex
- •Caregiver has not opted out of receiving text communication from the clinic
- •Valid mailing address and telephone number listed in the electronic health record
- •Parents and/or Caregivers
- •Parent or legal caregiver of an eligible child
- •Responsible for the child's care and able to provide consent for program participation
- •Aged 5 to 12 years at time of identification
- •Meet all criteria listed above
排除标准
- •Child has a medical condition or contraindication that precludes participation in moderate physical activity
- •Child has severe cognitive or physical impairment that would prevent participation in the intervention
- •Child or family is currently participating in another structured weight management or obesity treatment program
- •Family opts out of receiving study-related communications
研究组 & 干预措施
TM-Single
Participants receive a single bidirectional text message from the research team with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program.
干预措施: Text Message-based recruitment (Behavioral)
TM-Single-AO
Participants receive a single bidirectional text message from the research team with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program, plus telephone outreach from the local Community Implementation Team.
干预措施: Text Message-based recruitment (Behavioral)
TM-Single-AO
Participants receive a single bidirectional text message from the research team with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program, plus telephone outreach from the local Community Implementation Team.
干预措施: Active outreach follow-up (Behavioral)
TM-Repeat
Participants receive repeated bidirectional text messages from the research team over a 3-month period, with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program. Participants may opt out of receiving messages at any time.
干预措施: Text Message-based recruitment (Behavioral)
TM-Repeat-AO
Participants receive repeated bidirectional text messages from the research team over a 3-month period, with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program, plus telephone outreach from the local Community Implementation Team. Participants may opt out of receiving messages at any time.
干预措施: Text Message-based recruitment (Behavioral)
TM-Repeat-AO
Participants receive repeated bidirectional text messages from the research team over a 3-month period, with a one-touch response option and a direct link to enroll in the Family Healthy Weight Program, plus telephone outreach from the local Community Implementation Team. Participants may opt out of receiving messages at any time.
干预措施: Active outreach follow-up (Behavioral)
结局指标
主要结局
Reach: Enrollment in the Building Healthy Families Program
时间窗: Up to 3 months after initial outreach
Reach is defined as the proportion of eligible families who enroll in the Building Healthy Families program following outreach through population health management strategies. Enrollment is operationalized as completion of the BHF orientation session after responding to text messaging and/or active outreach recruitment strategies. Reach will be compared across randomized recruitment strategies that vary by text message frequency (single vs repeated outreach) and the presence or absence of active telephone outreach from the Community Implementation Team.
Program Attendance (Participant Retention)
时间窗: 12 months after enrollment
Attendance is defined as the proportion of scheduled BHF sessions attended by enrolled families during the program delivery period. Attendance data will be captured through the BHF program data portal and reflects ongoing engagement with the intervention following enrollment.
次要结局
- Child BMI z-score(Baseline, 3 months, and 12 months after enrollment.)
- Change in parent/caregiver weight(Baseline, 3 months, and 12 months after enrollment)
- Number of Communities Adopting Building Healthy Families(Up to 4 years)
- Direct observation of Implementation fidelity(Up to 12 months after program initiation)
- Number of Communities Maintaining BHF delivery(Up to 24 months after program initiation.)
研究者
Paul Estabrooks
Associate Dean of Community Engagement, College of Health and Professor in the Department of Health & Kinesiology
University of Utah