Women's Lifestyle Balance Study

NCT03184337 | Completed

• 1 other identifier: LB Study
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PreDiabetes; Metabolic Syndrome; Overweight

Keywords

Weight loss; Women; Sleep; Intervention; Diet; Physical activity; Fitbit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Change in sleep duration (objective)

  Baseline and 6 weeks, 3 months, and 6 months after start of intervention

• Change in sleep quality (self-report)

  Baseline and 6 weeks, 3 months, and 6 months after start of intervention

• Change in physical activity (objective)

  Baseline and 6 weeks, 3 months, and 6 months after start of intervention

• Change in physical activity (self-report)

  Baseline and 6 weeks, 3 months, and 6 months after start of intervention

• Change in caloric intake

  Baseline and 6 weeks, 3 months, and 6 months after start of intervention

Study Arms (2)

Active Control

ACTIVE COMPARATOR

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

Behavioral: CDC's PreventT2 Program

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

Interventions

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.

Active Control

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.

Experimental

Eligibility Criteria

• Age: 30 Years - 70 Years
• Gender Eligibility Details: Only participant's who self-identify as women will be eligible for this pilot study. If it the results are promising, a larger trial with both genders will be pursued.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143-0606, United States

Location

Related Publications (1)

• 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.

  PMID: 32757824 DERIVED

MeSH Terms

Conditions

Prediabetic State; Metabolic Syndrome; Overweight; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• Catherine Chesla, RN, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to one of two groups.

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 12, 2017
• Study Start: April 24, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)