Jump Start Shared Medical Appointments for Diabetes With Weight Management

NCT01973972 | Completed Results DMC

• 1 other identifier: IIR 13-053
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed research will test a novel program that combines intensive weight management with shared (group) medical appointments for patients with diabetes. This research is important because diabetes is increasingly prevalent, it requires complex management by the provider and the patient, and weight loss is a critical component of its management. Adding weight management to shared medical appointments could potentially improve blood sugar control while reducing medications and their side effects such as low blood sugar.

Conditions

Diabetes

Keywords

Diabetes; Obesity; Complex Care; Primary Care; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  measure of glycemic control

  48 weeks

Secondary Outcomes (4)

• Hypoglycemic Events

  through 48 weeks

• Medication Effect Score

  48 weeks

• Weight

  48 weeks

• Estimated Costs of Intervention Strategies

  through 48 weeks

Study Arms (2)

Weight management/shared medical appointment (WM/SMA)

EXPERIMENTAL

Weight management group visits every 2 weeks for 16 weeks using low-carbohydrate diet followed by group visits every 8 weeks (total of 48 weeks) for weight and diabetes management.

Behavioral: Weight management; Behavioral: Shared medical appointments (SMA)

Shared medical appointments (SMA)

ACTIVE COMPARATOR

Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management.

Behavioral: Shared medical appointments (SMA)

Interventions

Weight management BEHAVIORAL

Weight management group visits using low-carbohydrate diet followed for weight management.

Weight management/shared medical appointment (WM/SMA)

Shared medical appointments (SMA) BEHAVIORAL

Diabetes management group visits for diabetes management.

Shared medical appointments (SMA); Weight management/shared medical appointment (WM/SMA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes,
• Hemoglobin A1c \>= 8.0% or , \>= 7.5 for those less than 50
• BMI \>= 27 kg/m2,
• Interest in losing weight,
• Agrees to attend regular visits per study protocol,
• Has access to reliable transportation,
• Has a VAMC provider.

You may not qualify if:

• Age \>= 75 years old,
• Hemoglobinopathy that interferes with measurement of hemoglobin A1c,
• Certain chronic or unstable diseases that may put the participant at increased risk. These include the following:
• Kidney disease (serum creatinine \>1.5 mg/dL in men, \>1.3 mg/dL in women),
• Type 1 diabetes,
• Unstable CHD (unstable angina, current/active coronary ischemia workup),
• Blood pressure 160/100 mm Hg,
• Fasting triglycerides 600 mg/dL,
• Fasting serum LDL-C 190 mg/dL,
• Pregnancy, breastfeeding, or lack of birth control if premenopausal,
• Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g. illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year),
• Enrollment in another research study that might affect the main outcomes of this study.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

Related Publications (5)

• Crowley MJ, Edelman D, Voils CI, Maciejewski ML, Coffman CJ, Jeffreys AS, Turner MJ, Gaillard LA, Hinton TA, Strawbridge E, Zervakis J, Barton AB, Yancy WS Jr. Jump starting shared medical appointments for diabetes with weight management: Rationale and design of a randomized controlled trial. Contemp Clin Trials. 2017 Jul;58:1-12. doi: 10.1016/j.cct.2017.04.004. Epub 2017 Apr 23.

  PMID: 28445783 RESULT

• McVay MA, Yancy WS Jr, Bennett GG, Jung SH, Voils CI. Perceived barriers and facilitators of initiation of behavioral weight loss interventions among adults with obesity: a qualitative study. BMC Public Health. 2018 Jul 11;18(1):854. doi: 10.1186/s12889-018-5795-9.

  PMID: 29996812 RESULT

• Yancy WS Jr, Crowley MJ, Dar MS, Coffman CJ, Jeffreys AS, Maciejewski ML, Voils CI, Bradley AB, Edelman D. Comparison of Group Medical Visits Combined With Intensive Weight Management vs Group Medical Visits Alone for Glycemia in Patients With Type 2 Diabetes: A Noninferiority Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):70-79. doi: 10.1001/jamainternmed.2019.4802.

  PMID: 31682682 RESULT

• Alexopoulos AS, Yancy WS, Edelman D, Coffman CJ, Jeffreys AS, Maciejewski ML, Voils CI, Sagalla N, Barton Bradley A, Dar M, Mayer SB, Crowley MJ. Clinical associations of an updated medication effect score for measuring diabetes treatment intensity. Chronic Illn. 2021 Dec;17(4):451-462. doi: 10.1177/1742395319884096. Epub 2019 Oct 25.

  PMID: 31653175 RESULT

• Sagalla N, Yancy WS Jr, Edelman D, Jeffreys AS, Coffman CJ, Voils CI, Alexopoulos AS, Maciejewski ML, Dar M, Crowley MJ. Factors associated with non-adherence to insulin and non-insulin medications in patients with poorly controlled diabetes. Chronic Illn. 2022 Jun;18(2):398-409. doi: 10.1177/1742395320968627. Epub 2020 Oct 25.

  PMID: 33100020 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Obesity; Chronic Disease

Interventions

Shared Medical Appointments

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Appointments and Schedules; Organization and Administration; Health Services Administration; Practice Management, Medical; Practice Management; Professional Practice

Limitations and Caveats

Original target N not reached due to limited eligible and interested patients. Updated sample size calculation assuming 15% attrition and 1.4% standard deviation for hemoglobin A1c yielded N=254 for 80% power for the non-inferiority hypothesis.

Results Point of Contact

• Title: William S. Yancy, Jr.
• Organization: Duke University

yancy006@mc.duke.edu

919-681-2863

Study Officials

• William S Yancy, MD MHS

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 1, 2013
• Study Start: December 12, 2014
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: July 28, 2023
• Results First Posted: September 16, 2019

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)