NCT04784130

Brief Summary

The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week modified diabetes and hypertension self-management program using trained Health Coaches.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

4.1 years

First QC Date

July 29, 2020

Last Update Submit

January 31, 2024

Conditions

Diabetes Mellitus, Type 2Hypertension

Keywords

diabeteshypertensionself-management

Outcome Measures

Primary Outcomes (2)

  • Clinical outcomes-BP

    Difference in BP between baseline and end of program

    6 months after enrollment

  • Clinical Outcomes-A1c

    Difference in A1c between baseline and end of program

    6 months after enrollment

Secondary Outcomes (6)

  • Behavioral outcome - dietary modification for high fat foods; question

    6 months after enrollment

  • Behavioral outcome - healthy eating plan; questions

    6 months after enrollment

  • Behavioral outcome - dietary modification for fruits and vegetables; questions

    6 months after enrollment

  • Behavioral outcome - Activity log; Step count, using pedometer

    6 months after enrollment

  • Behavioral outcome - exercise; questions

    6 months after enrollment

  • +1 more secondary outcomes

Study Arms (3)

DHSMP core

EXPERIMENTAL

Dietary Modification and Physical Activity

Behavioral: Physical ActivityBehavioral: Dietary Modification

DHSMP core plus

EXPERIMENTAL

Dietary Modification, physical activity and medication adherence

Behavioral: Physical ActivityBehavioral: Medication AdherenceBehavioral: Dietary Modification

DHSMP control

ACTIVE COMPARATOR

enhanced usual care-3 hours of education plus materials.

Behavioral: Physical Activity

Interventions

Physical ActivityBEHAVIORAL

Respondents will complete activity logs (step count, using pedometer) and surveys (two items from the Summary of Diabetes Self-care activities measure) for physical activity.

DHSMP controlDHSMP coreDHSMP core plus
Medication AdherenceBEHAVIORAL

Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).

DHSMP core plus
Dietary ModificationBEHAVIORAL

Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.

DHSMP coreDHSMP core plus

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking adults ≥ 18 years of age;
  • co-occurring diagnosis of type 2 diabetes and hypertension
  • body mass index ≥ 25.0
  • willing to be randomized, and complete the intervention and all assessments.

You may not qualify if:

  • currently pregnant or breastfeeding
  • diagnosed with a severe mental illness
  • have any condition that requires physical activity limitations or is contraindicated for the Dietary Assessment to Stop Hypertension (DASH) diet
  • inability to complete the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clark K. Sleeth Family Medicine Center

Morgantown, West Virginia, 26501-9190, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2HypertensionDiabetes Mellitus

Interventions

ExerciseDiet Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutrition TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2020

First Posted

March 5, 2021

Study Start

October 1, 2019

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)