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Completed

NCT Number: NCT03184337

Women's Lifestyle Balance Study

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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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CDC's PreventT2 Program

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.

CDC's PreventT2 Program with Added Sleep Content

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Acronym: LB

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 12, 2017
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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