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 volunteersQualifiers
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
Single group
Treatments tested in this trial
Medical Nutrition Therapy
BehavioralCounselling
Treatment groups
Trial outcomes
Primary outcomes
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
body weight measured at the five post-baseline follow-up points
This is an indices used in the estimation of BMI
Secondary outcomes
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.
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).
Dietary Intake
24-hour dietary will be used to estimate the dietary intake of the participants
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)
Sponsors and contacts
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The University of Texas Medical Branch, Galveston
Lead sponsor
American Diabetes Association
Collaborator