Women's Lifestyle Balance Study (LB)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Overweight; Metabolic Syndrome; PreDiabetes

Treatments: Behavioral: CDC's PreventT2 Program; Behavioral: CDC's PreventT2 Program with Added Sleep Content

Study type: Interventional

Funder types: Other

Identifiers

NCT03184337

LB Study

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 26 patients

Sex: Female

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Active Control

Active Comparator group

Description:

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

Treatment:

Behavioral: CDC's PreventT2 Program

Experimental

Experimental group

Description:

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.

Treatment:

Behavioral: CDC's PreventT2 Program with Added Sleep Content