Clinical trial NCT04734015: Together Overcoming Diabetes
Official title: Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Diabetes
Family Intervention
Lifestyle Intervention
Indigenous
American Indian
Native American
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-02-02
Enrollment: 162
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Waitlist Control Design. Adult/youth participant dyads will be randomized to either the intervention group or the wait-list control group after eligibility screening, enrollment and completion of the baseline assessment.

The intervention group will receive the 6-month intervention and 6-month maintenance phase immediately; the wait-list will receive standard care for 24 months and will then receive the intervention.
Primary purpose: TREATMENT

Brief summary: Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention.

Participants in this trial are American Indian adult caregivers diagnosed with type 2 diabetes and their youth, aged 10-16 years at enrollment. Adult/youth participant dyads will be enrolled across 5 Ojibwe tribal communities. Consenting participant dyads will be randomized into one of two groups:

Group A: begin the intervention program immediately; Group B (waitlist): begin the intervention program in 2 years.

Both groups will complete assessments with study staff at baseline, 3, 6, 12, 18, and 24 months to assess HbA1c, cholesterol, blood pressure (adults), biometric measures, and psychosocial and behavioral outcomes (adults and youth).

The 14-lesson intervention program will be delivered in the participant's home by local Family Health Coaches over a 6-month period.

Upon completion of the intervention, participants may also be invited to participate in a "Ripple Effects Mapping" (REM) session for discussions, and mapping of the intervention effects.

Detailed description: Together Overcoming Diabetes (TOD) is a culturally tailored, family-based type 2 diabetes management and preventive intervention. The program activates family and cultural practices that encourage healthy diets and physical activities, promotes coping skills for dealing with stress, and reconnects families via a home-based intervention taught by American Indian (AI) paraprofessional Family Health Coaches.

Evaluation of TOD for this trial will happen via Community Based Participatory Research (CBPR). The study team will enroll "target" adult caregivers diagnosed with type 2 diabetes and their youth, ages 10-16 years at enrollment, with the goal of tapping motivational reciprocity between the two generations. The work involves collaboration with five Ojibwe tribal communities in the midwestern U.S. to implement a randomized controlled study with a wait-list design respectful of cultural norms of inclusion.

The study will evaluate effectiveness of the intervention on adult physiological (primary outcome = HbA1c), behavioral, and mental health and children's psychosocial, familial, behavioral and physiological risk and protective factors for diabetes. The research will also identify stress-coping mechanisms that mediate the impact of the intervention on health. A novel collaborative, qualitative evaluation technique will map potential "ripple effects" of the intervention within families and communities. If effective, the intervention will promote dissemination and scaling with tribal health coaches, community involvement, and stakeholder (health providers, health and human service agencies) input.

Eligibility criteria: Inclusion Criteria:

ADULT (target participants)

* Are greater than 18 years of age
* Self-identify as American Indian
* Have a completed verification form from a healthcare provider indicating a confirmed diagnosis of type 2 diabetes
* Live on or within 30 miles of participating reservations
* Are a caregiver to a 10-16 year-old who lives in their home
* Are willing to be randomly put into Group A (intervention) or Group B (waitlist control)
* Are willing to complete all lessons and assessments
* Speak and read English
* Are not cognitively or visually impaired (able to review and sign informed consent and complete assessments)

YOUTH

* 10 -16 years of age
* Self-identify as American Indian
* Live with an adult who has joined the study
* Are willing to be randomly put into Group A or Group B
* Are willing to complete all lessons and assessments
* Speak and read English
* Are not cognitively or visually impaired (able to review and sign informed consent and complete assessments)

Exclusion Criteria:

ADULTS (target participants)

* Are not American Indian
* No confirmed type 2 diabetes diagnosis
* Not a caregiver to a youth ages 10-16 in their home
* Does not live within the distance inclusion criteria
* Is unable to complete the study procedures
* Has comorbidity(ies) that may have an impact on type 2 diabetes management

YOUTH

* Are not American Indian
* Do not fall within the specified age range of 10-16 years at time of enrollment
* Do not have an enrolled Adult caregiver
* Unable to read and speak English
* Not willing to complete the study procedures

Primary outcomes:
measure: Change in Adult Participant Fasting HbA1c
timeFrame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Secondary outcomes:
measure: Change in BMI/zBMI - Adult and Youth participants
timeFrame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
measure: Change in Depression and Depressive symptoms - Adult and Youth participants
timeFrame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Other outcomes:
measure: Change in Physical Activity - Adult and Youth participants
timeFrame: Day 0, Month 6, Month 12, and Month 24
measure: Change in Communal Mastery - Adult and Youth participants
timeFrame: Day 0, Month 6, Month 12, and Month 24
measure: Change in Diabetes Empowerment - Adult participants
timeFrame: Day 0, Month 6, Month 12, and Month 24
Locations:
city: Duluth
country: United States
facility: Johns Hopkins University Great Lakes Hub
state: Minnesota
Study officials:
affiliation: Johns Hopkins University, Bloomberg School of Public Health
name: Melissa Walls, PhD
role: PRINCIPAL_INVESTIGATOR
References: