Type 2 Diabetes
Conditions
Keywords
Diabetes, Family Intervention, Lifestyle Intervention, Indigenous, American Indian, Native American
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.
Interventions
BEHAVIORALTogether 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.
Sponsors
Johns Hopkins Bloomberg School of Public Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
An Independent Evaluation team will conduct assessments and be blinded to participant randomization status. The investigators will also be blinded to randomization status during data collection and initial analyses.
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.
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Adult Participant Fasting HbA1c | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 | Change in Adult Participant Fasting HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI - Adult Participants | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 | BMI change as indication of weight loss |
| Change in zBMI - Youth Participants | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 | z-score of BMI in children and adolescents that indicates the number of standard deviations away from the mean. A z-score of 0 is equal to the population mean, based on age and sex. A lower z-score represents a better outcome (less obesity), with scores between -1.0 and +1.0 indicating normal weight. Numbers greater than -1.0 and +1.0 indicate overweight status. |
| Change in Depression and Depressive Symptoms - Adult Participants | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 | Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 27. Higher total score equates to worse outcome. |
| Change in Depression and Depressive Symptoms - Youth Participants | Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 | Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 27. Higher total score equates to worse outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMelissa Walls, PhD
Johns Hopkins University, Bloomberg School of Public Health
Participant flow
Recruitment details
128 adult/youth dyads submitted Interest Forms. 47 adult/youth dyads were excluded: 23 dyads did not meet inclusion criteria, 13 dyads the adult declined to enroll, 11 dyads were unresponsive/unable to contact.
Pre-assignment details
A total of 162 participants (81 adults and 81 youth) were enrolled and randomized after completing the Baseline assessment. 82 participants (41 adults and 41 youth) were assigned to the Intervention group to immediately receive the TOD curriculum while 80 participants (40 adults and 40 youth) were assigned to the Waitlist group and received the intervention after completion of assessment visits (baseline, 3 months, 6 months, 12 months, 18 months, and 24 months).
Baseline characteristics
| Characteristic | — |
|---|---|
| Adult participant Fasting HbA1c | 7.93 Percentage Glycated Hemoglobin STANDARD_DEVIATION 1.99 |
| Age, Continuous Adults | 48.71 Years STANDARD_DEVIATION 12.22 |
| Age, Continuous Youth | 13.2 Years STANDARD_DEVIATION 1.7 |
| Race (NIH/OMB) Adults American Indian or Alaska Native | 41 Participants |
| Race (NIH/OMB) Adults Asian | 0 Participants |
| Race (NIH/OMB) Adults Black or African American | 0 Participants |
| Race (NIH/OMB) Adults More than one race | 0 Participants |
| Race (NIH/OMB) Adults Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Adults Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Adults White | 0 Participants |
| Race (NIH/OMB) Youth American Indian or Alaska Native | 81 Participants |
| Race (NIH/OMB) Youth Asian | 0 Participants |
| Race (NIH/OMB) Youth Black or African American | 0 Participants |
| Race (NIH/OMB) Youth More than one race | 0 Participants |
| Race (NIH/OMB) Youth Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Youth Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Youth White | 0 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 10 Participants |
| Sex/Gender, Customized Youth gender Boy | 17 Participants |
| Sex/Gender, Customized Youth gender Different identity | 2 Participants |
| Sex/Gender, Customized Youth gender Girl | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 41 | 0 / 41 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 41 | 0 / 41 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 1 / 41 | 0 / 41 | 0 / 40 | 0 / 40 |
Outcome results
None listed