Cognitive Behavioral Sleep Intervention for Prevention of Type 2 Diabetes

A Pilot Study of a Cognitive Behavioral Sleep Intervention for the Prevention of Type 2 Diabetes

The proposed study aims to evaluate if improving sleep could enhance the intensive lifestyle intervention for improving weight loss and glycemic control in prediabetic individuals who have insomnia with short sleep duration. A cognitive behavioral intervention for insomnia with adjustments aimed at increasing sleep duration (CBT-Sleep) will be used for this study.

Study Overview

• Status: Suspended
• Conditions: Insomnia; PreDiabetes; Sleep Deprivation
• Intervention / Treatment: Behavioral: Intensive Lifestyle Intervention; Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hpspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• (a) Hong Kong residents,
• (b) BMI > 23kg/m2,
• (c) aged 18 to 65 year-old,
• (d) have prediabetes, defined by a plasma fasting glucose concentration of 5.6 to 6.9 mmol/L, impaired glucose tolerance (2hglucose 7.8-11.0 on OGTT), or HbA1c 5.7-6.4%,
• (e) have average habitual sleep duration < 6.5 hours, confirmed by actigraphy measure of sleep for 2 weeks or have insomnia, confirmed in a clinical sleep interview and actigraph-measure of greater than 30 minutes of sleep onset latency or nighttime awakening for 3 nights or more per week

Exclusion Criteria:

• (a) have unmanaged sleep apnea or other sleep disorders,
• (b) have any current severe mental illnesses,
• (c) have any medical conditions or medication use that could undermine the efficacy of the sleep intervention,
• (d) have shift work schedules,
• (e) have any environmental constraints on the feasibility of implementing a sleep schedule of at least 7.5 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Intensive Lifestyle Intervention (ILI); The ILI will consist of 8 group-based 90-min sessions focusing on modifying dietary and exercise habits with the goal of reducing 450kcal of daily calories and increasing physical activity to 150 minutes of exercise per week.	Behavioral: Intensive Lifestyle Intervention; This intervention is an abbreviated version of the Diabetes Prevention Program, which has been shown to be effective in reducing the risk of developing type 2 diabetes.
EXPERIMENTAL: ILI enhanced with cognitive behavioral sleep intervention; The ILI+Sleep intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session.	Behavioral: Intensive Lifestyle Intervention enhanced with Cognitive Behavioral Sleep Intervention; This intervention will consist of the same 8 sessions of ILI with additions of sleep components in each session. The additional sleep components will include (a) psychoeducation about the importance of sleep in weight control and glycemic control, (b) sleep hygiene, (c) stimulus control, (d) modifying maladaptive beliefs about sleep, (e) and, setting individualized sleep schedule and reviewing sleep schedule.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in HbA1C (%)	12 weeks from baseline
Changes in fasting glucose concentration (mg/dl)	12 weeks from baseline
Changes in 2-hr oral glucose tolerance (mg/dl)	12 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in insomnia symptom severity	measured by the Insomnia Severity Index. The score ranges from 0 to 28. The higher the score, the greater the symptom severity	12 weeks from baseline
Changes in subjective sleep onset latency	measured by daily sleep diary	12 weeks from baseline
Changes in subjective wake after sleep onset	measured by daily sleep diary	12 weeks from baseline
Changes in subjective total sleep time	measured by daily sleep diary	12 weeks from baseline
Changes in objective sleep onset latency	measured by actigraphy	12 weeks from baseline
Changes in objective wake after sleep onset	measured by actigraphy	12 weeks from baseline
Changes in objective total sleep time	measured by actigraphy	12 weeks from baseline
Changes in body weight (kg)		12 weeks from baseline
Changes in psychological distress	the validated Chinese version of the Depression Anxiety Stress Scales (DASS-21)will be used. The score ranges from 0 to 63. The higher the score, the greater the distress	12 weeks from baseline
Changes in quality of life	the validated Chinese version of the Satisfaction with Life Scale will be used to measure quality of life. The score ranges from 5 to 35. The higher the score, the greater the quality of life	12 weeks from baseline
Changes in food craving	Measured by the Food Craving Questionnaire. The score ranges from 10 to 70. The higher the score, the greater the food craving	12 weeks from baseline
Changes in acceptance of physical activity	Measured by the Physical Activity Acceptance and Action Questionnaire. The score ranges from 10 to 70. The higher the score, the greater acceptance.	12 weeks from baseline
Changes in weight loss self efficacy	Measured by the Weight Loss Self Efficacy Scale. The score ranges from 0 to 100%. The higher the percentage, the greater the self-efficacy	12 weeks from baseline
Changes in weight control strategies	Measured by the Weight Control Strategy Scale. The score ranges from 0 to 120. The higher the percentage, the more effective strategies are used	12 weeks from baseline
Changes in dietary composition	Measured by the Chinese version of the 7-day Food Frequency Questionnaire	12 weeks from baseline

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: June 26, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 17, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Lifestyle Intervention; Cognitive Behavioral Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Sleep Deprivation
• Other Study ID Numbers: EA1909037; UW20-245 (OTHER: HKU/HA HKW IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be shared with other researchers for review purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No