Women's Lifestyle Balance Study

Not Applicable

Completed

• Conditions: Overweight; PreDiabetes; Metabolic Syndrome
• Interventions: Behavioral: CDC's PreventT2 Program; Behavioral: CDC's PreventT2 Program with Added Sleep Content

• Registration Number: NCT03184337
• Lead Sponsor: University of California, San Francisco

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).

Study Timeline

• Study Start: 2017-04-24
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-06-09
• Study First Posted: 2017-06-12
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Control	CDC's PreventT2 Program	Participants in the active control group will receive 8 group sessions of the CDC's PreventT2 program.
Experimental	CDC's PreventT2 Program with Added Sleep Content	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 sleep quality (self-report)	Baseline and 6 weeks, 3 months, and 6 months after start of intervention	Pittsburgh Sleep Quality Index (PSQI)
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 leptin levels	Baseline and 6 weeks after start of intervention	Leptin levels will be used to measure the hormone that regulates satiety
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 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 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
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 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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States