Women's Lifestyle Balance Study



Status:Completed
Conditions:Obesity Weight Loss, Endocrine, Endocrine, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:30 - 70
Updated:10/27/2018
Start Date:April 24, 2017
End Date:December 31, 2017

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

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.

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).

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)
We found this trial at
1
site
San Francisco, California 94143
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from
San Francisco, CA
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