Family PALS (PArtners in Lifestyle Support)

Diabetes Mellitus Clinical Trial

— PALS  

Official title:

Family Diabetes Study (Family PALS (PArtners in Lifestyle Support)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01324011
• Other study ID #: 10-1449
• Secondary ID: K01DK080079
• Status: Completed
• Phase: N/A
• First received: March 24, 2011
• Last updated: July 15, 2013
• Start date: January 2011
• Est. completion date: September 2012

Study information

• Verified date: July 2013
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

NOTE: This study is in the trial-phase of a 5-year study that included a formative research phase (Phase 1 - IRB study # 07-1765 "Family-based Diabetes Self-management Training for African American Adults"). During the first phase, eight focus groups were conducted with 68 participants and a validation study with 215 African American patients with type 2 diabetes. The data gathered in Phase 1 informs the refinement of the intervention in this phase.

Purpose: The overall goal of this research is to evaluate, in a randomized controlled trial, a family-based diabetes self-management intervention for overweight/obese African American adults with type 2 diabetes (the "index participants") and a paired overweight family member (co-participant) who does not have diabetes. The primary outcome is weight change in the index participant.

Description:

Type 2 diabetes disproportionately burdens African Americans, and already excessive rates of diabetes are expected to increase even further as rates of obesity rise. While there is evidence that diabetes self-management training is effective in improving metabolic control, and modest weight loss can delay the onset of diabetes, the investigators have limited knowledge of the best approach to self-management training from a family perspective in high risk groups such as African Americans. Family remains a valued dimension of African American life and may be an important behavioral context for interventions to improve disease management and health outcomes. Nonetheless, there are no trials of family-based interventions to improve diabetes self-care and achieve weight loss that have involved adult families.

Participants: A total of 80 pairs (index participant + family member) or 160 adults will participate in this trial where a 20-session behavioral weight loss intervention will be tested. Participants include overweight or obese African Americans with type 2 diabetes and a paired co-participant identified as an overweight or obese adult family member without type 2 diabetes. Family members may self-describe as non-African Americans.

Procedures (methods): Study participants will be enrolled in a randomized controlled trial using a 2:1 random allocation to the special intervention (a 20-session family-based behavioral weight loss intervention) or a usual care group (controls). Following the trial, participants in the usual care group will receive a 6-session weight management intervention (over a 2-month period) based on the 20-session special intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

Person with diabetes.

Inclusion Criteria:

• self-described African American 21-75 years of age;

• self-reported diagnosis of type 2 diabetes;

• A1c value = 11%;

• currently under the care of a physician or other health care provider;

• able to participate in moderate level physical activity;

• willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and physical activity patterns;

• access to a phone and willing to complete a telephone-administered survey;

• English speaking.

Exclusion Criteria:

• any medical contraindication to weight loss;

• cardiovascular event within the past 6 months;

• evidence of active cancer diagnosis;

• pregnant or lactating;

• self-reported history of renal disease other than kidney stones;

• any history of gastric bypass surgery or scheduled surgery for this purpose;

• weight loss of >20 lbs in the last 3 months;

• current use of medications for weight loss, treatment of psychosis or manic-depressive illness.

Family Members: Inclusion criteria (NOTE: 'Family' for this study is defined as 'a group of intimates living together or in close proximity with strong emotional bonds (identification, attachment, loyalty, reciprocity, solidarity), and with strong, ongoing personal ties. Family members can only participate if paired with an African American study participant.):

• 21 -75 years of age;

• living with or married (for at least 1 year) to an African American adult diagnosed with diabetes;

• self-described as a blood relative of an African American with diabetes with whom there is regular, ongoing contact;

• overweight/obesity defined as a BMI between 25 to 47, inclusive;

• English-speaking;

• able to participate in moderate level physical activity;

• willing to lose 5% or more of initial body weight and follow recommendations for healthy dietary and physical activity patterns;

• access to a phone and willing to complete a telephone-administered survey.

Exclusion Criteria:

• self-reported diagnosis of type 2 diabetes (the A1c test used in this study cannot be used for diagnostic purposes; additionally, the initial therapy of most newly diagnosed patients with type 2 diabetes includes lifestyle changes and weight loss);

• any medical contraindication to weight loss;

• cardiovascular event within the past 6 months;

• evidence of active cancer diagnosis;

• pregnant or lactating;

• self-reported history of renal disease other than kidney stones;

• any history of gastric bypass surgery or scheduled surgery for this purpose;

• weight loss of > 20 lbs in the last 3 months;

• current use of medications for weight loss, treatment of psychosis or manic-depressive illness.

Family members do not themselves have to be self-described African Americans.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Adult diabetes family-based weight loss intervention
Participants assigned to the experimental group will begin the 2o-week weight loss intervention, while delayed intervention controls will wait until the end of this period to begin their program. The weight loss intervention includes 20 weekly group-based sessions facilitated by a registered dietitian. Each group session will last about 120 minutes and include: weight check, group sharing and problem-solving, discussion of a weight control topics (nutrition, physical activity, or behavior change), physical activity and/or taste-testing. Ten sessions will include a brief component, focused on improving family relationships for better diabetes self-care. The study weight loss goal is =10 pounds (minimum rate-0.5 lb/week; maximum-2 lbs/week). While the control group waits, they will receive 1 newsletter with study updates and general health or diabetes information. The delayed intervention includes 6 sessions (4 weekly + 2 bi-weekly) following the same format as the experimental group.

Locations

Country	Name	City	State
United States	UNC Center for Health Promotion and Disease Prevention (HPDP)	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Change in weight from start to end of the 20-weekly group-based intervention. NOTE: Weekly sessions are not held during weeks where holidays occur on a scheduled session date (such that the duration of the intervention may be more than 20 weeks).	6 months	No
Secondary	Effect on Hemoglobin A1c	A1c change from enrollment to post-intervention.	6 months (post-intervention)	No
Secondary	Lifestyle behaviors	Diet and physical activity behavior changes (from enrollment or baseline to post-intervention)	6 months	No
Secondary	Blood pressure change	Change in systolic and diastolic blood pressure from baseline (enrollment) to post-intervention	6 months	No
Secondary	Change in psychosocial factors	Changes in measures of family functioning, social support and social relationships, self-efficacy, perceived barriers to diabetes self-care, and quality of life; comparing baseline to post-intervention.	6 months	No