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Jump Start Shared Medical Appointments for Diabetes With Weight Management

Jump Starting Shared Medical Appointments for Diabetes With Weight Management

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01973972
Acronym
Jump Start
Enrollment
263
Registered
2013-11-01
Start date
2014-12-12
Completion date
2018-07-31
Last updated
2023-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Obesity, Complex Care, Primary Care, Chronic Disease

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.

Detailed description

Anticipated Impacts on Veteran's Healthcare: Weight management is an important focus of VA as evidenced by its VA/DoD Clinical Practice Guideline and MOVE! program targeting overweight/obesity. VA is also committed to using group visits to increase the efficiency and effectiveness of health care delivery. The investigators aim to test a novel intervention that combines intensive weight and diabetes management using the SMA platform. This research addresses important missions to VA because diabetes is more prevalent in Veterans than in the general population, and because weight management is more challenging and complex in patients with diabetes. Project Background: SMAs involve groups of patients who share a common chronic condition and meet over time to receive education, self-management enhancement, and medication management to improve clinical outcomes. A systematic review by VA found that SMAs modestly improve glycemia in patients with diabetes. Although these SMA programs sometimes included diet and physical activity counseling, weight management was not a primary goal, and weight typically was not reduced. Instead, medication intensification was the primary strategy for improving glycemia, and this strategy can lead to weight gain. For overweight patients with diabetes, weight loss is first-line therapy because it can improve glycemic control and because excess weight leads to poorer outcomes. Moreover, many antiglycemic medications cause weight gain and hypoglycemic events, which may counteract the potential macrovascular benefits of glycemic control. Dietary interventions, however, can lower weight and improve glycemic control while reducing antiglycemic medication needs and, therefore, subsequent risk for hypoglycemic episodes. In prior research, the investigators induced weight loss and improved glycemic control while decreasing antiglycemic medications. A combination of an intensive weight management program with the diabetes management offered in SMAs has potential to further improve diabetes outcomes, reduce complications, decrease costs and increase health-related quality of life. Such a combined intervention is ideal for patients with diabetes because of their unique dietary considerations, and their need for careful glycemic and medication management during weight loss. Project Objectives: The investigators will examine whether an intensive, group-based weight management program followed by an SMA intervention (WM/SMA arm) is comparably effective (non-inferior) to the SMA intervention alone for improving glycemic control while using less antiglycemic medication and resulting in fewer hypoglycemic events and lower healthcare costs. Project Methods: 308 overweight VA outpatients with uncontrolled (hemoglobin A1c 8.0% or 7.5% or greater for those under 50) type 2 diabetes will participate in this RCT. Similar to prior SMAs, the SMA visits will occur every 4 weeks for 16 weeks and then every 8 weeks for 32 weeks for a total of 9 visits. Sessions will be led by a physician and trained interventionists, and will include educational topics related to diabetes management (including diet and physical activity), self-management training, and medication adjustment. Similar to the investigators' prior weight management trials, the WM/SMA group will meet every 2 weeks for 16 weeks and then every 8 weeks for 32 weeks for a total of 13 visits. The weight management program will focus on a low carbohydrate dietary pattern because of its potential to lower glycemia, leading to reduced antiglycemic medication needs. After 16 weeks, meeting content will shift to the SMA intervention content but weight management will continue to be addressed at the meetings. The primary outcome is glycemic control assessed by hemoglobin A1c assessed at baseline and at 16, 32, and 48 weeks. Secondary outcomes include hypoglycemic events, changes in the antiglycemic medication regimen as assessed by a summary score, weight and healthcare costs. Diabetes-specific health-related quality of life and medication adherence will also be assessed.

Interventions

BEHAVIORALWeight management

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

BEHAVIORALShared medical appointments (SMA)

Diabetes management group visits for diabetes management.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Hemoglobin A1c48 weeksmeasure of glycemic control

Secondary

MeasureTime frameDescription
Hypoglycemic Eventsthrough 48 weeksAll episodes of hypoglycemia will be recorded by participants on provided standard log forms, noting the date, time, duration, symptoms, treatment received, and concurrent blood glucose. Participants will additionally be asked if they received medical attention for hypoglycemia, and the details if so, since the last assessment. Only one episode will be counted per 24 hours. Serious episodes, defined as \<50 mg/dL or 50-69 mg/dL and requiring assistance, will supersede minor episodes in this case.
Medication Effect Score48 weeksAntiglycemic medications, dosages, and schedules will be assessed carefully with the participant and updated at each visit. A Medication Effect Score (MES), based on the potencies and dosages of the medications in a patient's regimen, was devised to reflect the overall intensity of antiglycemic medication. The MES is calculated as the percentage taken of the maximum dose multiplied by the expected hemoglobin A1c lowering effect for each of a participant's medications, which are then summed. Its range is 0 to infinite, with higher scores meaning higher diabetes medication requirement.
Weight48 weeksweight by electronic scale
Estimated Costs of Intervention Strategiesthrough 48 weeksEstimates of intervention costs, utilities, direct and indirect costs using market lab cost estimates

Countries

United States

Participant flow

Participants by arm

ArmCount
Weight Management/Shared Medical Appointment (WM/SMA)
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. Weight management: Weight management group visits using low-carbohydrate diet followed for weight management. Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
127
Shared Medical Appointments (SMA)
Diabetes management group visits every 4 weeks for 16 weeks followed by group visits every 8 weeks (total of 48 weeks) for diabetes management. Shared medical appointments (SMA): Diabetes management group visits for diabetes management.
136
Total263

Baseline characteristics

CharacteristicWeight Management/Shared Medical Appointment (WM/SMA)Shared Medical Appointments (SMA)Total
Age, Continuous61.0 years
STANDARD_DEVIATION 8.1
60.4 years
STANDARD_DEVIATION 8.3
60.7 years
STANDARD_DEVIATION 8.2
Body mass index35.6 kg/m^2
STANDARD_DEVIATION 5.4
35.0 kg/m^2
STANDARD_DEVIATION 4.8
35.3 kg/m^2
STANDARD_DEVIATION 5.1
Hemoglobin A1c9.0 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.3
9.2 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.3
9.1 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.3
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants2 Participants3 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
64 Participants79 Participants143 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
60 Participants52 Participants112 Participants
Region of Enrollment
United States
127 participants136 participants263 participants
Sex: Female, Male
Female
17 Participants11 Participants28 Participants
Sex: Female, Male
Male
110 Participants125 Participants235 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
2 / 1272 / 136
other
Total, other adverse events
12 / 1279 / 136
serious
Total, serious adverse events
27 / 12727 / 136

Outcome results

Primary

Hemoglobin A1c

measure of glycemic control

Time frame: 48 weeks

ArmMeasureValue (MEAN)Dispersion
Weight Management/Shared Medical Appointment (WM/SMA)Hemoglobin A1c8.2 percentage of glycosylated hemoglobinStandard Deviation 1.6
Shared Medical Appointments (SMA)Hemoglobin A1c8.3 percentage of glycosylated hemoglobinStandard Deviation 1.4
Secondary

Estimated Costs of Intervention Strategies

Estimates of intervention costs, utilities, direct and indirect costs using market lab cost estimates

Time frame: through 48 weeks

ArmMeasureValue (MEAN)
Weight Management/Shared Medical Appointment (WM/SMA)Estimated Costs of Intervention Strategies1513.42 U.S. dollars
Shared Medical Appointments (SMA)Estimated Costs of Intervention Strategies1264.49 U.S. dollars
Secondary

Hypoglycemic Events

All episodes of hypoglycemia will be recorded by participants on provided standard log forms, noting the date, time, duration, symptoms, treatment received, and concurrent blood glucose. Participants will additionally be asked if they received medical attention for hypoglycemia, and the details if so, since the last assessment. Only one episode will be counted per 24 hours. Serious episodes, defined as \<50 mg/dL or 50-69 mg/dL and requiring assistance, will supersede minor episodes in this case.

Time frame: through 48 weeks

ArmMeasureValue (MEAN)
Weight Management/Shared Medical Appointment (WM/SMA)Hypoglycemic Events3.2 events
Shared Medical Appointments (SMA)Hypoglycemic Events6.6 events
Secondary

Medication Effect Score

Antiglycemic medications, dosages, and schedules will be assessed carefully with the participant and updated at each visit. A Medication Effect Score (MES), based on the potencies and dosages of the medications in a patient's regimen, was devised to reflect the overall intensity of antiglycemic medication. The MES is calculated as the percentage taken of the maximum dose multiplied by the expected hemoglobin A1c lowering effect for each of a participant's medications, which are then summed. Its range is 0 to infinite, with higher scores meaning higher diabetes medication requirement.

Time frame: 48 weeks

ArmMeasureValue (MEAN)Dispersion
Weight Management/Shared Medical Appointment (WM/SMA)Medication Effect Score2.2 units on a scaleStandard Deviation 1.5
Shared Medical Appointments (SMA)Medication Effect Score2.7 units on a scaleStandard Deviation 2
Secondary

Weight

weight by electronic scale

Time frame: 48 weeks

ArmMeasureValue (MEAN)Dispersion
Weight Management/Shared Medical Appointment (WM/SMA)Weight104.3 kgStandard Deviation 20.3
Shared Medical Appointments (SMA)Weight108.0 kgStandard Deviation 19.5

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026