Women's Lifestyle Balance Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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PreDiabetes, Metabolic Syndrome, Overweight

Intervention / Treatment
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* Behavioral: CDC's PreventT2 Program
* Behavioral: CDC's PreventT2 Program with Added Sleep Content


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be assigned to one of two groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Control<br>Participants in the active control group will receive 8 group sessions of the CDC's PreventT2 program. | Behavioral: CDC's PreventT2 Program<br>* 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.<br>|
| Experimental: Experimental<br>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. | Behavioral: CDC's PreventT2 Program with Added Sleep Content<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body mass index | Body mass index is calculated as the participant's body weight divided by the square of their height. | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep duration (objective) | Nighttime sleep duration will be objectively assessed over 7 days using a Fitbit monitor | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | 
| Change in sleep quality (self-report) | Pittsburgh Sleep Quality Index (PSQI) | 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 | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | 
| Change in physical activity (self-report) | International Physical Activity Questionnaire (IPAQ) | 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 | 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 | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | 
| Change in HbA1c | HbA1c blood tests will be used to measure average blood glucose levels. | 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 | 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. | Baseline and 6 weeks after start of intervention | 
| Change in leptin levels | Leptin levels will be used to measure the hormone that regulates satiety | 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 | 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 | 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. | 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 | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight loss, Women, Sleep, Intervention, Diet, Physical activity, Fitbit