Skip to main content
OpenTrials
Completed

NCT Number: NCT05395377

Preventing Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

About this study

The primary aim of this study was to demonstrate that an increased recruitment rate for weight loss intervention can be achieved within patients that have pre-diabetes by communicating personalized risk of progression to type 2 diabetes, by estimating risk reduction with weight loss, and by offering program choice. Secondary aims included program participation rate, weight loss, and short term decreased diabetes risk.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Registered Dietitian/Nutritionist

Behavioral

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

Diabetes Prevention Program

Behavioral

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

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.

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.

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.

Primary outcomes

  1. Demographics

    Time frame: Baseline

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

  2. Body Weight

    Time frame: 12 Months

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

  3. Pre-Diabetes Indicator

    Time frame: 12 months

    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.

  4. Patient-Centered Outcomes

    Time frame: 12 months

    Treatment satisfaction and patient involvement in care survey

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Registry information

Official study title

Preventing Diabetes Among Patients With Pre-Diabetes by Improving Patient-Activation and Enhancing Clinical Decision Support for Weight Management to Lower Costs

Acronym: PD

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
May 27, 2022
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.