Together Overcoming Diabetes

Type 2 Diabetes Clinical Trial

— TOD  

Official title:

Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04734015
• Other study ID #: DK091250
• Secondary ID: 5R01DK091250-07I
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 18, 2021
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 162
• Est. completion date: June 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• Together Overcoming Diabetes (TOD)
Curriculum approaches health through a holistic lens of spiritual, mental, physical and emotional wellness. American Indian Family Health Coaches conduct motivational interviewing to help participant dyads (adult caregivers with Type 2 diabetes and their youth) set attainable goals and work through obstacles to reach those goals.

Locations

Country	Name	City	State
United States	Johns Hopkins University Great Lakes Hub	Duluth	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Physical Activity - Adult and Youth participants	Survey questions will ask about physical activity duration, frequency, intensity. Higher score equates to better outcome.	Day 0, Month 6, Month 12, and Month 24
Other	Change in Communal Mastery - Adult and Youth participants	Communal Mastery as a Coping Resource. Scoring ranges from 0 to 3. Higher score equates to better outcome.	Day 0, Month 6, Month 12, and Month 24
Other	Change in Diabetes Empowerment - Adult participants	Diabetes Empowerment Scale (short form, Anderson, et al., 2003). Scoring ranges from 0 to 3. Higher score equates to better outcome.	Day 0, Month 6, Month 12, and Month 24
Primary	Change in Adult Participant Fasting HbA1c	Change in hemoglobin A1c	Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Secondary	Change in BMI/zBMI - Adult and Youth participants	zBMI change as indication of weight loss	Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Secondary	Change in Depression and Depressive symptoms - Adult and Youth participants	Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 3. Higher total score equates to worse outcome.	Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24