Women's Lifestyle Balance Study (LB)

October 24, 2018 updated by: University of California, San Francisco

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in body mass index
Time Frame: 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.
Baseline and 6 weeks, 3 months, and 6 months after start of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in sleep duration (objective)
Time Frame: 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
Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in sleep quality (self-report)
Time Frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Pittsburgh Sleep Quality Index (PSQI)
Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in physical activity (objective)
Time Frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
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)
Time Frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
International Physical Activity Questionnaire (IPAQ)
Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in caloric intake
Time Frame: 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
Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in self-reported dietary intake
Time Frame: 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
Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in HbA1c
Time Frame: Baseline and 3 months, and 6 months after start of intervention
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)
Time Frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
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)
Time Frame: 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.
Baseline and 6 weeks after start of intervention
Change in leptin levels
Time Frame: Baseline and 6 weeks after start of intervention
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)
Time Frame: 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
Baseline and 6 weeks, 3 months, and 6 months after start of intervention
Change in blood pressure
Time Frame: Baseline and 6 weeks, 3 months, and 6 months after start of intervention
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
Time Frame: Baseline and 6 months after start of intervention
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
Time Frame: 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
Baseline and 6 weeks, 3 months, and 6 months after start of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Catherine Chesla, RN, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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