Getting in Balance: A Workplace Diabetes Prevention Intervention Trial

NCT02589873 | Completed

• 1 other identifier: CN-15-2318-H
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates two group-based Diabetes Prevention Program (DPP) lifestyle interventions delivered in the workplace to individuals at risk for pre-diabetes: 1) an in-person group-based lifestyle intervention; and 2) an internet-based intervention delivered using an online platform with lifestyle coaching support. Eligible participants will be randomized equally to each intervention program (120 participants in each).

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Keywords

Lifestyle Intervention; Workplace; Diabetes Prevention

Outcome Measures

Primary Outcomes (1)

• Body weight lost

  Percentage of body weight lost and the amount of weight lost (in pounds) on average over the 12 month follow-up, and at 6 and 12 months compared to baseline, by intervention arm. Body weight will be collected at baseline, 6 months, and 12 months.

  12 months

Secondary Outcomes (4)

• Change in minutes of physical activity

  12 months

• Change in dietary fat intake

  12 months

• Participant engagement

  12 months

• Stress and well-being

  12 months

Study Arms (2)

In-Person Diabetes Prevention Program

ACTIVE COMPARATOR

An in-person group delivery modality of a CDC recognized Diabetes Prevention Program (DPP), delivered by the Young Men's Christian Association (YMCA). This group receives lifestyle coaching in a group setting, meeting weekly for 16 weeks followed by 3 biweekly sessions, and 5 monthly maintenance sessions.

Behavioral: In-Person Diabetes Prevention Program

Online Diabetes Prevention Program

ACTIVE COMPARATOR

An online delivery modality of a CDC recognized Diabetes Prevention Program (DPP), delivered by Canary Health's Virtual Lifestyle Management program. This group completes online learning sessions weekly for 16 weeks followed by 8 monthly maintenance sessions.

Behavioral: Online Diabetes Prevention Program

Interventions

In-Person Diabetes Prevention Program BEHAVIORAL

Lifestyle intervention program involving group-based educational sessions, diet and physical activity tracking, and weekly weigh ins. Participants complete the intervention over 12 months.

Also known as: YMCA DPP

In-Person Diabetes Prevention Program

Online Diabetes Prevention Program BEHAVIORAL

Lifestyle intervention program involving web-based educational videos, diet and physical activity tracking, and recording weight. Participants complete the intervention over 12 months.

Also known as: Virtual Lifestyle Management

Online Diabetes Prevention Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ethnicity: All ethnic groups;
• Sex: all genders;
• Age (as of date of enrollment): Lower age limit: 18 years; Upper age limit: NONE;
• Body mass index ≥ 25.0 kg/m2; ≥23 kg/m2 if Asian
• Having pre-diabetes based on a score of 9+ on the CDC pre-diabetes screener
• Able and willing to enroll and provide written, informed consent, i.e., to:
• meet the time and data collection requirements of the study;
• be randomized to one of the two intervention programs;
• adhere to the recommendations of the study intervention as assigned; and
• participate in follow-up for 12 months.

You may not qualify if:

• Does not work at one of the participating employer work locations/departments;
• Inability to speak, read, or understand English;
• No regular access to a computer with internet capabilities;
• Diagnosis of Type 1 or Type 2 diabetes mellitus;
• Systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≥ 100 mm Hg on more than one occasion during the last year;
• Having a medical or physical condition that make moderate intensity physical activity (like a brisk walk) difficult or unsafe, such as exercise induced asthma or chronic obstructive pulmonary disease (COPD);
• Use of weight-loss medications in the past 3 months;
• Regular use (\> 5 days/month) of medications that affect appetite or weight (e.g., oral corticosteroids, insulin, oral hypoglycemics etc.);
• Currently enrolled in a weight loss program;
• Planning to undergo bariatric surgery during the study period;
• Heart disease (angina, heart attack (myocardial infarction), congestive heart failure (CHF)), stroke;
• Renal insufficiency;
• Diagnosis of cancer (other than non-melanoma skin cancer) that was active or treated with radiation or chemotherapy within the past 2 years;
• Pregnant, lactating or planning to become pregnant during the study period;
• Already enrolled or planning to enroll in a research study that would limit full participation in this study or confound the observation and interpretation of the study's findings;

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

City and County of San Francisco

San Francisco, California, 94103, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Assiamira Ferrara, MD, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 28, 2015
• Study Start: September 1, 2015
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

US (1)