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Completed

NCT Number: NCT02589873

Getting in Balance: A Workplace Diabetes Prevention Intervention Trial

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City and County of San Francisco

San Francisco, California, 94103, United States

About this study

The study seeks to compare weight loss, changes in physical activity and dietary fat intake, and participant engagement in two Diabetes Prevention Program (DPP) interventions derived from the Centers for Disease Control and Prevention (CDC) curriculum: an in-person and an internet-based intervention program.

We hypothesize that the internet-based intervention will be more effective in achieving weight loss than the in-person intervention, given its convenience for participants to complete sessions and therefore greater potential engagement in the program.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Planning to transfer to another department location during the study period;
  • Planning to move out of the area during the study period;
  • Investigator discretion for clinical safety or protocol adherence reasons.

Treatment and study plan

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.

Other names: YMCA DPP

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.

Other names: Virtual Lifestyle Management

Primary outcomes

  1. Body weight lost

    Time frame: 12 months

    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.

Secondary outcomes

  1. Change in minutes of physical activity

    Time frame: 12 months

    Change in physical activity duration per week - measured using the International Physical Activity Questionnaire (IPAQ);

  2. Change in dietary fat intake

    Time frame: 12 months

    Change in daily dietary fat intake - measured using the Block Fat Screener

  3. Participant engagement

    Time frame: 12 months

    Participant engagement - measured by the number of intervention sessions completed by 6 months, as well as the number of maintenance sessions completed between 6 and 12 months.

  4. Stress and well-being

    Time frame: 12 months

    Change in well-being - measured using SF-8 Health Survey

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Registry information

Official study title

A Workplace Intervention Trial Comparing Two Diabetes Prevention Programs - In-person and Online - Delivered in a Large Urban Workplace Environment.

Acronym: GIBW

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2015
Registry last updated
Oct 10, 2018

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.

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