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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
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.
University of California, San Francisco
San Francisco, California, United States
Change in body mass index
Body mass index is calculated as the participant's body weight divided by the square of their height.
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in sleep duration (objective)
Nighttime sleep duration will be objectively assessed over 7 days using a Fitbit monitor
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in sleep quality (self-report)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in physical activity (objective)
Daily step counts over 7 days using a Fitbit monitor
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in physical activity (self-report)
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in caloric intake
Daily calories consumed over 7 days and recorded using a Fitbit monitor
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in self-reported dietary intake
'Starting the Conversation' will be used to assess self-reported dietary intake
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
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Change in HbA1c
HbA1c blood tests will be used to measure average blood glucose levels.
Time frame: Baseline and 3 months, and 6 months after start of intervention
Change in Fasting Plasma Glucose (FPG)
FPG will be used to measure current blood glucose levels
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR is calculated from fasting plasma glucose and insulin levels and will be used to measure insulin resistance.
Time frame: Baseline and 6 weeks after start of intervention
Change in leptin levels
Leptin levels will be used to measure the hormone that regulates satiety
Time frame: Baseline and 6 weeks after start of intervention
Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
A standard lipid panel will be used to measure cardiovascular risk factors
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in blood pressure
Blood pressure will be used as a measure of cardiovascular risk
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in waist circumference
Waist circumference will be used to measure central adiposity, an indicator of cardiovascular risk.
Time frame: Baseline and 6 months after start of intervention
Change in self-assessed general health
The Promis General Health measure will be used to assess the participant's perception of their general health
Time frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention