Women's Lifestyle Balance Study

Metabolic Syndrome Clinical Trial

— LB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184337
• Other study ID #: LB Study
• Status: Completed
• Phase: N/A
• Start date: April 24, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2018
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glucose Intolerance
• Metabolic Syndrome
• Metabolic Syndrome X
• Overweight
• PreDiabetes
• Prediabetic State
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in sleep quality (self-report)	Pittsburgh Sleep Quality Index (PSQI)	Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Secondary	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
Secondary	Change in physical activity (self-report)	International Physical Activity Questionnaire (IPAQ)	Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in leptin levels	Leptin levels will be used to measure the hormone that regulates satiety	Baseline and 6 weeks after start of intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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