Adapting the Diabetes Prevention Program for a Developing World Context

Adapting the Diabetes Prevention Program for a Developing World Context



Sponsors


Source

Children's Mercy Hospital Kansas City

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

This study will examine whether an adapted version of ]he Diabetes Prevention Program (DPP)
can be effective when delivered by community health workers (CHWs) in a poor urban community
in South Africa. We will randomize existing groups that are part of an non-governmental
organization's (NGO) chronic disease management program (anticipated cluster N = 54;
anticipated individual N=540), to receive either the program or usual care (wait-list). The
primary outcome analysis will compare percentage of baseline weight loss at Y1 between the
program and usual care; however, after Y1 usual care participants will also receive the
program and both groups will be followed for another year.

Overall Status

Not yet recruiting

Start Date

2018-02-01

Completion Date

2020-02-01

Primary Completion Date

2020-02-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Weight loss
1 year

Secondary Outcome

Measure

Time Frame

Blood pressure
1 year
HbA1c
1 year
LDL cholesterol
1 year
Triglycerides
1 year

Enrollment

540

Condition


Intervention

Intervention Type

Behavioral

Intervention Name


Description

Participants will receive group weight loss sessions addressing healthy eating, exercise, and weight loss principles adapted from the Diabetes Prevention Program delivered by Community Health Workers.

Arm Group Label

Lifestyle Program Intervention


Intervention Type

Other

Intervention Name


Description

Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.

Arm Group Label

Lifestyle Program Intervention

Wait list




Eligibility

Criteria

Inclusion Criteria:

- member of participating partner NGO "health club" (members are medically stabilized
individuals with diabetes mellitus or hypertension referred for disease and lifestyle
management)

- BMI greater than or equal to 25 kg per meter squared

Exclusion Criteria:

- unsafe level of blood pressure (over 160 (systolic) and over 100 mm (diastolic)) at
screening

- elevated blood sugar (A1C greater than or equal to 8) at screening

- being pregnant, breast-feeding or planning pregnancy within 2 years

- chronic use of oral steroid medication

- intellectual disabilities that would prevent ability to understand the program

- not intending to stay in the health club over the next 2 years

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Contact

Last Name

Sarah Schlachter

Phone

816-701-5266

Email



Location

Facility

Status

Contact

University of the Western Cape
Cape Town South Africa
Not yet recruiting
Last Name: Thandi Puoane, PhD

Location Countries

Country

South Africa


Verification Date

2017-11-01

Lastchanged Date

2017-11-10

Firstreceived Date

2017-11-10

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Children's Mercy Hospital Kansas City

Investigator Full Name

Delwyn Catley

Investigator Title

Principal Investigator


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Lifestyle Program Intervention

Arm Group Type

Experimental

Description

Participants receive usual care and group weight loss sessions adapted from the Diabetes Prevention Program delivered by Community Health Workers.


Arm Group Label

Wait list

Arm Group Type

Other

Description

Participants receive usual care and after 1 year receive the Lifestyle Program intervention



Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

After the end of year 1 outcomes the control arm crosses over and a year 2 follow-up is conducted on both arms.

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

November 10, 2017

Study First Submitted Qc

November 10, 2017

Study First Posted

November 14, 2017

Last Update Submitted

November 10, 2017

Last Update Submitted Qc

November 10, 2017

Last Update Posted

November 17, 2017


ClinicalTrials.gov processed this data on November 17, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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