Promoting Intergenerational Health in Rural Kentuckians With Diabetes (PIHRK'D)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Medical Branch, Galveston

About this trial

The goal of this feasibility study is to use family units as support to promote nutrition and physical activity of individuals with type 2 diabetes. The main question it aims to answer is:

• How does the family structure impact the health of its members living with type 2 diabetes?

Participants will be asked to;

* Tell us about their access to food sources and places in the community to engage in physical activity. * A nutrition and physical activity plan will be developed for participants and their families to use for 6 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

must be diagnosed with type 2 diabetes

must be from rural Kentucky

must be living in rural Kentucky for at least 1 year

Disqualifiers

potential participants without consent

Trial design

Design model

Single group

Treatments tested in this trial

  • Medical Nutrition Therapy

    Behavioral

    Counselling

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Medical Nutrition TherapyOther 1 intervention

Trial outcomes

Primary outcomes

1

hemoglobin A1c values measured at the five post-baseline follow-up points

This is a test that measures average blood sugar levels over the past 3 months

Time frame
baseline, 3 months, 6 months, 9 months and 12 months
2

body weight measured at the five post-baseline follow-up points

This is an indices used in the estimation of BMI

Time frame
baseline, 3 months, 6 months, 9 months and 12 months

Secondary outcomes

1

Diabetes Knowledge

Diabetes knowledge of the participants will be assessed using a validated Diabetes Knowledge Questionnaire (DKQ). The DKQ is a 24-item questionnaire, designed by Starr County Diabetes Education Study, to elicit information about patients' understanding of the cause of their disease, its associated complications, blood glucose levels, diet, and physical activity. The DKQ has three response options "yes", "no", and "don't know". One point is awarded for each correct option, whereas, no point or negative scoring for the incorrect option. Its scoring involves summing-up the points obtained by each participant. A higher score represents better disease knowledge.

Time frame
baseline, 3 months, 6 months, 9 months and 12 months
2

Diabetes self-management

Diabetes self-management/self-efficacy will be assessed using the Diabetes Empowerment Scale. Diabetes Empowerment Scale is a 28-item scale that measures diabetes-related psychosocial self-efficacy with an overall Cronbach's uses 3 subscales: Managing the Psychosocial Aspects of Diabetes, Assessing Dissatisfaction and Readiness to Change, and Setting and Achieving Diabetes Goals (Anderson et al, 2000). The questionnaires consist of 28 items with 3 subscales, with each item rated along a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The range of score is divided in three subgroups as low (28-65 scores), middle (66-103) and high (104-140).

Time frame
baseline, 3 months, 6 months, 9 months and 12 months
3

Dietary Intake

24-hour dietary will be used to estimate the dietary intake of the participants

Time frame
baseline, 3 months, 6 months, 9 months and 12 months
4

Diabetes Distress

The Diabetes Distress Scale (DDS) is a 17-item scale that measures patient concerns about disease management, support, emotional burden and access to care. The response scale for each question ranges from "1" (not a problem) to "6" (a very serious problem). An average score of greater than or equal to 3 indicated moderate distress and discriminated between high and low distressed groups (Fisher et al, 2008)

Time frame
baseline, 3 months, 6 months, 9 months and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Medical Branch, Galveston

Lead sponsor

American Diabetes Association

Collaborator