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Summary

Eligibility
for females ages 30–70
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

This pilot study aims to determine whether adding a sleep extension and sleep hygiene intervention to an existing lifestyle improvement program improves its efficacy for weight loss in those at risk for diabetes and cardiovascular disease. Half of the participants will receive the Centers for Disease Control's standard PreventT2 program and half of the participants will receive the same program with an additional sleep intervention.

Official Title

Women's Lifestyle and Sleep Intervention for Prediabetes and Metabolic Syndrome

Details

The goal of this pilot study is to determine whether the efficacy of an existing lifestyle improvement program can be increased by adding a sleep extension and sleep hygiene intervention. Improved sleep can improve weight loss through two possible routes: lessening fatigue may potentiate physical activity (PA), and decreasing appetite may potentiate diet improvements. A sample of 24-30 women will be assigned to either the Centers for Disease Control's (CDC's) standard PreventT2 program or the same program with an additional integrated sleep intervention. Both programs will involve 8 group sessions administered over 3 months, and all women will be followed for a total of 6 months. The primary outcome is weight loss, and secondary outcomes include sleep quality and duration, physical activity, caloric intake, and physiological indicators of cardiovascular and diabetes risk (HbA1c, HOMA-IR, lipids, blood pressure). The combined program has the potential to significantly improve weight loss in those at risk for diabetes and cardiovascular disease (CVD).

Keywords

PreDiabetes Metabolic Syndrome Overweight Weight loss Women Sleep Intervention Diet Physical activity Fitbit

Eligibility

You can join if…

Open to females ages 30–70

  • Female (or self-identify as female)
  • Age 30-70 years
  • BMI 25-38 (or 23-38 if Asian or other Pacific Islander)
  • Time in bed <= 7 hours on a typical weeknight
  • Meets diagnostic criteria for prediabetes and/or metabolic syndrome

You CAN'T join if...

  • No regular access to telephone or email (for maintaining contact);
  • No access to smartphone, tablet, or laptop computer (for using Fitbit);
  • Having a condition that limits physical activity, such as brisk walking;
  • Having a diagnosis of type 1 or type 2 diabetes or been previously treated with diabetes medications;
  • Having a cardiac event or cardiac surgery in the past year;
  • Having a metabolic condition that prevents weight loss;
  • Working night shift (Midnight - 4 AM)
  • Inability to complete the baseline assessment (REDCap survey and Fitbit tracking of activity, diet, and sleep for 7 days)

Location

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03184337
Lead Scientist
Catherine Chesla
Study Type
Interventional
Last Updated
June 1, 2017