Clinical trial NCT03184337: Women's Lifestyle Balance Study
Official title: Women's Lifestyle and Sleep Intervention for Prediabetes and Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Metabolic Syndrome
Overweight
Keywords: Weight loss
Women
Sleep
Intervention
Diet
Physical activity
Fitbit
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 26
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two groups.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change in body mass index
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Secondary outcomes:
measure: Change in sleep duration (objective)
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
measure: Change in sleep quality (self-report)
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
measure: Change in physical activity (objective)
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
measure: Change in physical activity (self-report)
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
measure: Change in caloric intake
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
measure: Change in self-reported dietary intake
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
measure: Change in HbA1c
timeFrame: Baseline and 3 months, and 6 months after start of intervention
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
measure: Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline and 6 weeks after start of intervention
measure: Change in leptin levels
timeFrame: Baseline and 6 weeks after start of intervention
measure: Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
measure: Change in blood pressure
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
measure: Change in waist circumference
timeFrame: Baseline and 6 months after start of intervention
measure: Change in self-assessed general health
timeFrame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Catherine Chesla, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.