Preventing Diabetes

NCT05395377 | Completed

• 1 other identifier: 2017-0394
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to improve the quality of weight management care for patients with pre-diabetes and overweight or obesity. Personalized risk profiles, clinical decision support, and patient-centered decision tools for understanding pre-diabetes risk and the likelihood of preventing diabetes with a modest 5-7% weight loss will be developed. This project will offer patients their choice of effective weight management treatment options, each containing the cornerstone of weight management- intensive lifestyle intervention. Patients and PCPs will be better informed and equipped with information that helps them make weight management treatment decisions that work the best for their lifestyle, and each is expected to produce at least 5-7% weight loss over 6 months.

Conditions

PreDiabetes

Outcome Measures

Primary Outcomes (4)

• Demographics

  Race, ethnicity, education level, marital status, household income, and weight management history.

  Baseline

• Body Weight

  The study's primary outcome is change in body mass index (in kg) from baseline to 12-month follow-up.

  12 Months

• Pre-Diabetes Indicator

  At baseline, 6 months,12 months, we will assess HbA1c from the intervention participants. These measures will provide important information about changes in participants' risk and prevention of diabetes.

  12 months

• Patient-Centered Outcomes

  Treatment satisfaction and patient involvement in care survey

  12 months

Study Arms (5)

Registered Dietitian/Nutritionist

ACTIVE COMPARATOR

Behavioral: Registered Dietitian/Nutritionist

DPP Group Classes

ACTIVE COMPARATOR

Behavioral: Diabetes Prevention Program

Weight Watchers, Reimagined

ACTIVE COMPARATOR

Behavioral: Weight Watchers, Reimagined

Pharmacological Treatment

ACTIVE COMPARATOR

Behavioral: DPP or RDN Counseling + Medication

Bariatric Surgery Evaluation

ACTIVE COMPARATOR

Other: Bariatric Surgery Evaluation

Interventions

Registered Dietitian/Nutritionist BEHAVIORAL

Participants received a FitBit Flex and Intensive Lifestyle Intervention coaching via telephone with Registered Dietitian/Nutritionist.

Registered Dietitian/Nutritionist

Diabetes Prevention Program BEHAVIORAL

Modified DPP group classes lead by a Registered Dietitian and Exercise Physiologist.

DPP Group Classes

Weight Watchers, Reimagined BEHAVIORAL

Participants in this group were provided with an online access code to enroll in WW and could choose the format of their choice- group, online, and/or smartphone app.

Weight Watchers, Reimagined

DPP or RDN Counseling + Medication BEHAVIORAL

Participants met with a weight management specialist to receive weight loss medications, as well as, receiving either the DPP or Registered Dietitian coaching. Medications utilized in this study were Phentermine and Metformin. Metformin was prescribed if the participant could not tolerate Phentermine.

Pharmacological Treatment

Bariatric Surgery Evaluation OTHER

Participants (BMI \> 40) were offered a consultation with the bariatric surgical program that requires lifestyle weight management during the first 6 months. Participants were also able to choose to receive one of the other 4 intervention options in the first six months prior to consideration for bariatric surgery.

Bariatric Surgery Evaluation

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least two weight measures within the last two 24 months, including most recent, that meet the following criteria:
• Prediabetes and BMI \>27: Treatment Option 1, 2, 3, or 4
• Prediabetes and BMI \>40: Treatment Options 1-5
• Most recent laboratory value that meets prediabetes indicators, per American Diabetes Association, 2016
• Hemoglobin A1C ≥5.7% and \<6.5%, or
• Fasting plasma glucose ≥100 mg/dl and \<126 mg/dl, or
• Oral glucose tolerance test ≥140 mg/dl and \<200 mg/dl

You may not qualify if:

• History of significant weight loss documented within 5 years,
• Contraindications to weight change (e.g., cancer, pregnancy)
• Prior bariatric surgery
• Weight loss medication use or orders within 5 years prior to the project.

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Nutritionists; dentin sialophosphoprotein; Dosage Forms

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Lisa Bailey-Davis, DEd

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants enrolled in this study were able to choose from 1 of 5 intervention options based on their weight status.

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: May 27, 2022
• Study Start: December 18, 2017
• Primary Completion: June 28, 2019
• Study Completion: November 16, 2021
• Last Updated: May 27, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)