Diabetes Medical Nutrition Therapy in Southeastern African American Women

NCT ID: NCT04971889

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-03

Study Completion Date

2025-07-31

Brief Summary

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A two-arm randomized controlled trial design will be used. Participants will include 291 African American women with type 2 diabetes that are at risk for development and/or progression of diabetes complications. Both arms, diabetes medical nutrition therapy (MNT) and diabetes MNT plus motivational interviewing (MI), will include: 1) a 3-month active intervention period of six biweekly (every other week), group-based, trained nutritionist-facilitated sessions; 2) a 3-month maintenance intervention period, which will include one group-based maintenance support session; and 3) a 6-month inactive period (no contact). The differences between arms is the integration of culturally-adapted MI exercises during the diabetes MNT plus MI active and maintenance intervention periods.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diabetes MNT plus MI

--Group-based dietary/dietary motivation intervention

Group Type ACTIVE_COMPARATOR

Diabetes MNT

Intervention Type BEHAVIORAL

Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake

Motivational Interviewing

Intervention Type BEHAVIORAL

Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise

Diabetes MNT

-Group-based dietary intervention

Group Type ACTIVE_COMPARATOR

Diabetes MNT

Intervention Type BEHAVIORAL

Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake

Interventions

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Diabetes MNT

Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake

Intervention Type BEHAVIORAL

Motivational Interviewing

Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* African American
* Female
* Clinical diagnosis of type 2 diabetes for at least 6 months
* At risk for development and/or progression of diabetes complications (HbA1c ≥ 7.0% AND either systolic blood pressure ≥130, LDL cholesterol ≥ 100, or BMI ≥ 30).

Exclusion Criteria

--Observed or diagnosed psychotic disorders
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Matthew Walker Comprehensive Health Center

UNKNOWN

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

Meharry Medical College

OTHER

Sponsor Role lead

Responsible Party

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Stephania T. Miller-Hughes

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Matthew Walker Comprehensive Health Center

Nashville, Tennessee, United States

Site Status NOT_YET_RECRUITING

Meharry Medical College

Nashville, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Stephania Miller-Hughes, PhD

Role: CONTACT

Phone: 16153275666

Email: [email protected]

Facility Contacts

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Katina Beard, MSPH

Role: primary

Stephania Miller-Hughes, PhD, MS, MSCI

Role: primary

References

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Miller ST, Akohoue SA, Murry VM, Tabatabai M, Wilus D, Foxx A. SISTER (Sisters Inspiring Sisters to Engage in Relevant Diabetes Self-Care) Diabetes Study: Protocol for diabetes medical nutrition therapy randomized clinical trial among African American women. Contemp Clin Trials. 2023 Feb;125:107052. doi: 10.1016/j.cct.2022.107052. Epub 2022 Dec 13.

Reference Type BACKGROUND
PMID: 36526256 (View on PubMed)

Other Identifiers

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21-02-1069

Identifier Type: -

Identifier Source: org_study_id