Metabolic Syndrome, Overweight, PreDiabetes
Conditions
Keywords
Weight loss, Women, Sleep, Intervention, Diet, Physical activity, Fitbit
Brief summary
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
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).
Interventions
BEHAVIORALCDC's PreventT2 Program
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.
BEHAVIORALCDC's PreventT2 Program with Added Sleep Content
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.
Sponsors
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants will be assigned to one of two groups.
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 70 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | Body mass index is calculated as the participant's body weight divided by the square of their height. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in physical activity (objective) | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | Daily step counts over 7 days using a Fitbit monitor |
| Change in physical activity (self-report) | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | International Physical Activity Questionnaire (IPAQ) |
| Change in caloric intake | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | Daily calories consumed over 7 days and recorded using a Fitbit monitor |
| Change in sleep duration (objective) | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | Nighttime sleep duration will be objectively assessed over 7 days using a Fitbit monitor |
| Change in self-reported dietary intake | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | 'Starting the Conversation' will be used to assess self-reported dietary intake |
| Change in HbA1c | Baseline and 3 months, and 6 months after start of intervention | HbA1c blood tests will be used to measure average blood glucose levels. |
| Change in sleep quality (self-report) | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | Pittsburgh Sleep Quality Index (PSQI) |
| Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline and 6 weeks after start of intervention | HOMA-IR is calculated from fasting plasma glucose and insulin levels and will be used to measure insulin resistance. |
| Change in leptin levels | Baseline and 6 weeks after start of intervention | Leptin levels will be used to measure the hormone that regulates satiety |
| Change in lipid profile (total cholesterol, LDL, HDL, triglycerides) | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | A standard lipid panel will be used to measure cardiovascular risk factors |
| Change in blood pressure | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | Blood pressure will be used as a measure of cardiovascular risk |
| Change in waist circumference | Baseline and 6 months after start of intervention | Waist circumference will be used to measure central adiposity, an indicator of cardiovascular risk. |
| Change in self-assessed general health | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | The Promis General Health measure will be used to assess the participant's perception of their general health |
| Change in Fasting Plasma Glucose (FPG) | Baseline and 6 weeks, 3 months, and 6 months after start of intervention | FPG will be used to measure current blood glucose levels |
Countries
United States
Outcome results
None listed