Women's Lifestyle Balance Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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PreDiabetes Metabolic Syndrome Overweight

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants will be assigned to one of two groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active Control

Participants in the active control group will receive 8 group sessions of the CDC's PreventT2 program.

Group Type ACTIVE_COMPARATOR

CDC's PreventT2 Program

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

CDC's PreventT2 Program with Added Sleep Content

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No