Women's Lifestyle Balance Study (LB)

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Metabolic Syndrome; PreDiabetes
• Intervention / Treatment: Behavioral: CDC's PreventT2 Program; Behavioral: CDC's PreventT2 Program with Added Sleep Content

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143-0606
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Control; Participants in the active control group will receive 8 group sessions of the CDC's PreventT2 program.	Behavioral: CDC'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.
Experimental: Experimental; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Catherine Chesla, RN, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Women; Sleep; Weight loss; Physical activity; Diet; Intervention; Fitbit
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Disease; Diabetes Mellitus; Body Weight; Insulin Resistance; Hyperinsulinism; Hyperglycemia; Syndrome; Metabolic Syndrome; Prediabetic State; Glucose Intolerance; Overweight
• Other Study ID Numbers: LB Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No