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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

Tracking Information
First Submitted Date  ICMJE January 25, 2021
First Posted Date  ICMJE February 2, 2021
Last Update Posted Date February 5, 2021
Estimated Study Start Date  ICMJE May 1, 2021
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 29, 2021)
Reduction in Adult Participant Fasting HbA1c [ Time Frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 ]
Reduction in hemoglobin A1c
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 2, 2021)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2021)
  • Reduction in BMI/zBMI - Adult and Youth participants [ Time Frame: Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24 ]
    zBMI reduction as indication of weight loss
  • Decrease 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.
Current Other Pre-specified Outcome Measures
 (submitted: February 2, 2021)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: January 29, 2021)
  • Increase 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.
  • Increase 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.
  • Increase 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.
 
Descriptive Information
Brief Title  ICMJE Together Overcoming Diabetes
Official Title  ICMJE Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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.

    Intervention: Behavioral: Together Overcoming Diabetes (TOD)
  • 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.

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2021)
560
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2024
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angie Forsberg 218-491-1710 aforsbe2@jhu.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04734015
Other Study ID Numbers  ICMJE DK091250
5R01DK091250-07 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Melissa Walls, PhD Johns Hopkins University, Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP