search
Back to results

Together Overcoming Diabetes (TOD)

Primary Purpose

Type 2 Diabetes

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Together Overcoming Diabetes (TOD)
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Family Intervention, Lifestyle Intervention, Indigenous, American Indian, Native American

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University Great Lakes Hub

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Together Overcoming Diabetes (TOD) curriculum

Waitlist Control

Arm Description

A randomized waitlist control trial (RCT) design will be employed with 81 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.

A randomized waitlist control trial (RCT) design will be employed with 81 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.

Outcomes

Primary Outcome Measures

Change in Adult Participant Fasting HbA1c
Change in hemoglobin A1c

Secondary Outcome Measures

Change in BMI/zBMI - Adult and Youth participants
zBMI change as indication of weight loss
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.

Full Information

First Posted
January 25, 2021
Last Updated
April 17, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT04734015
Brief Title
Together Overcoming Diabetes
Acronym
TOD
Official Title
Family-Based, Culturally-Centered Diabetes Intervention With Ojibwe Communities
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Family Intervention, Lifestyle Intervention, Indigenous, American Indian, Native American

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Together Overcoming Diabetes (TOD) curriculum
Arm Type
Experimental
Arm Description
A randomized waitlist control trial (RCT) design will be employed with 81 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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
A randomized waitlist control trial (RCT) design will be employed with 81 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.
Intervention Type
Behavioral
Intervention Name(s)
Together Overcoming Diabetes (TOD)
Other Intervention Name(s)
Niwii-shaagoojitoomin Izhi-Maamawi (we defeat/overcome it together)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Adult Participant Fasting HbA1c
Description
Change in hemoglobin A1c
Time Frame
Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Secondary Outcome Measure Information:
Title
Change in BMI/zBMI - Adult and Youth participants
Description
zBMI change as indication of weight loss
Time Frame
Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Title
Change in Depression and Depressive symptoms - Adult and Youth participants
Description
Patient Health Questionnaire (PHQ-9) Adult and Adolescent versions. Scoring ranges from 0 to 3. Higher total score equates to worse outcome.
Time Frame
Day 0, Month 3, Month 6, Month 12, Month 18, and Month 24
Other Pre-specified Outcome Measures:
Title
Change in Physical Activity - Adult and Youth participants
Description
Survey questions will ask about physical activity duration, frequency, intensity. Higher score equates to better outcome.
Time Frame
Day 0, Month 6, Month 12, and Month 24
Title
Change in Communal Mastery - Adult and Youth participants
Description
Communal Mastery as a Coping Resource. Scoring ranges from 0 to 3. Higher score equates to better outcome.
Time Frame
Day 0, Month 6, Month 12, and Month 24
Title
Change in Diabetes Empowerment - Adult participants
Description
Diabetes Empowerment Scale (short form, Anderson, et al., 2003). Scoring ranges from 0 to 3. Higher score equates to better outcome.
Time Frame
Day 0, Month 6, Month 12, and Month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Walls, PhD
Organizational Affiliation
Johns Hopkins University, Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University Great Lakes Hub
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55812
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Together Overcoming Diabetes

We'll reach out to this number within 24 hrs