Women's Lifestyle Balance Study (LB)

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).

Participants in the active control group will receive 8 group sessions of the CDC's PreventT2 program.

Participants in the experimental group will receive 8 group sessions of the CDC's PreventT2 Program with Added Sleep Content designed to extend and improve sleep.

The PreventT2 program will involve 8 group sessions administered over 3 months. It is a behavioral intervention focused on achieving weight loss by improving nutritional intake and increasing physical activity. It will also include individual biweekly phone calls for 6 months.

The CDC's PreventT2 program with added sleep content will involve 8 group sessions administered over 3 months. It is a behavioral intervention focused on achieving weight loss by improving sleep quality and nutritional intake and increasing sleep duration and physical activity. It will also include individual biweekly phone calls for 6 months.

Body mass index is calculated as the participant's body weight divided by the square of their height.

HOMA-IR is calculated from fasting plasma glucose and insulin levels and will be used to measure insulin resistance.

The Promis General Health measure will be used to assess the participant's perception of their general health

Only participant's who self-identify as women will be eligible for this pilot study. If it the results are promising, a larger trial with both genders will be pursued.

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)

Chesla CA, Gay C, Bauer L, Bender MS, Lee K. Preventing Type 2 Diabetes Among Midlife Women: A Feasibility Study Comparing a Combined Sleep and Lifestyle Intervention With a Standard Lifestyle Intervention. Diabetes Educ. 2020 Oct;46(5):424-434. doi: 10.1177/0145721720943128. Epub 2020 Aug 6.