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Together Overcoming Diabetes (TOD)

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ClinicalTrials.gov Identifier: NCT04734015
Recruitment Status : Not yet recruiting
First Posted : February 2, 2021
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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. A total of 280 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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Together Overcoming Diabetes (TOD) Not Applicable

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 (N = 280 family dyads) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized Waitlist Control Design. N = 280 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.

Masking: Single (Outcomes Assessor)
Masking Description: An Independent Evaluation team will conduct assessments and be blinded to participant randomization status.
Primary Purpose: Health Services Research
Official Title: Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Together Overcoming Diabetes (TOD) curriculum

A randomized waitlist control trial (RCT) design will be employed with 140 family dyads (adult caregiver and youth) randomly assigned to the Intervention group (Group A): Together Overcoming Diabetes (TOD).

Group A participant dyads will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.

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.
Other Name: Niwii-shaagoojitoomin Izhi-Maamawi (we defeat/overcome it together)

No Intervention: Waitlist Control

A randomized waitlist control trial (RCT) design will be employed with 140 family dyads (adult caregiver and youth) randomly assigned to the Waitlist Control group (Group B). Waitlist family dyads will not initially receive the intervention. They will be monitored via assessment of applicable biometric, psychosocial and behavioral outcomes at baseline, 3-months into intervention delivery, 6 months after baseline (post intervention), 12 months, 18 months, and 24 months.

Waitlist participant dyads will begin to receive the intervention program (TOD) approximately 24 months (2 years) after enrollment in the RCT.




Primary Outcome Measures :
  1. Change in Adult Participant Fasting HbA1c [ Time Frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 ]
    Change in hemoglobin A1c


Secondary Outcome Measures :
  1. Change in BMI/zBMI - Adult and Youth participants [ Time Frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 ]
    zBMI change as indication of weight loss

  2. Change in Depression and Depressive symptoms - Adult and Youth participants [ Time Frame: 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 3. Higher total score equates to worse outcome.


Other Outcome Measures:
  1. Change in Physical Activity - Adult and Youth participants [ Time Frame: Day 0, Month 6, Month 12, and Month 24 ]
    Survey questions will ask about physical activity duration, frequency, intensity. Higher score equates to better outcome.

  2. Change in Communal Mastery - Adult and Youth participants [ Time Frame: Day 0, Month 6, Month 12, and Month 24 ]
    Communal Mastery as a Coping Resource. Scoring ranges from 0 to 3. Higher score equates to better outcome.

  3. Change in Diabetes Empowerment - Adult participants [ Time Frame: Day 0, Month 6, Month 12, and Month 24 ]
    Diabetes Empowerment Scale (short form, Anderson, et al., 2003). Scoring ranges from 0 to 3. Higher score equates to better outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734015


Contacts
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Contact: Angie Forsberg 218-491-1710 aforsbe2@jhu.edu

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Melissa Walls, PhD Johns Hopkins University, Bloomberg School of Public Health
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT04734015    
Other Study ID Numbers: DK091250
5R01DK091250-07 ( U.S. NIH Grant/Contract )
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Diabetes
Family Intervention
Lifestyle Intervention
Indigenous
American Indian
Native American
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases