All-encompassing Program Led by Diabetes Specialist Team

NCT03497390 | Completed

• 1 other identifier: EMERALD
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

Obese type 2 diabetic patients are difficult to treat with many unmet needs requiring complex treatment regimens, intensive counselling and emotional support. Traditional anti-diabetic drugs, such as sulphonylureas and insulin, are known to have side-effects of weight gain and can offset the benefits of glycemic control and increase cardiovascular risks. Aside from these therapeutic challenges, psychological needs of these obese diabetic patients due to anxiety, stigmatization, stress, depression cannot be adequately addressed in a busy clinic setting. Here, the investigators propose to conduct this translational study aiming to compare the effects of a multi-component care program with personalized drug regimen augmented by behavioural therapy with psychological support and peer influence, led by a diabetes specialist team on metabolic control and psychobehavioural parameters in obese type 2 diabetic participants with poor glycemic control (glycated hemoglobin \[HbA1c\]\>8%) versus usual care. The 1-year multi-component program will be followed by a 2-year observational period in the EMERALD group. Outcome measures will be assessed in all participants in the EMERALD and usual care group at 1-year and 3-year. The primary outcome was between-group differences in HbA1c from baseline to year 1 and year 3. The secondary outcomes were the proportion of patients who attained key performance indexes (KPIs; defined by reduction \[Δ\] in HbA1c≥0.5%, ΔSBP≥5 mmHg, ΔLDL-cholesterol≥0.5 mmol/L and Δbody weight≥3%) and BMI\<25 kg/m2. systolic/diastolic BP, lipid levels (total cholesterol, LDL-cholesterol, triglyceride, high-density lipoprotein cholesterol \[HDL-cholesterol\]), obesity indices (body weight, BMI and waist circumference) and patient-reported outcomes. The latter included self-care and treatment adherence (assessed by 16-item Summary for Diabetes Self-Care Activities \[SDSCA-16\]), empowerment (assessed by Chinese Diabetes Empowerment Scale-10 \[CDES-10\]), quality of life (assessed by 5-item EuroQoL \[EQ-5D\]) and depression/anxiety (assessed by 9-item Patient Health Questionnaire \[PHQ-9\]) and 21-item Depression Anxiety Stress Scale \[DASS-21\]). A per-protocol analysis will be performed to assess the correlations between adherence to these activities and improvement in metabolic control.

Conditions

Health Care Delivery

Keywords

Type 2 diabetes; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in glycemic control

  Primary outcome measures will be a change from baseline HbA1c at 1-year and 3-year between the two groups.

  From baseline to 1-year and 3-year

Secondary Outcomes (5)

• Change in blood pressure (BP)

  From baseline to 1-year and 3-year

• Change in low-density lipoprotein (LDL) cholesterol

  From baseline to 1-year and 3-year

• Change in body mass index [BMI]

  From baseline to 1-year and 3-year

• Change in waist circumference [WC]

  From baseline to 1-year and 3-year

• Change in waist-hip ratio [WHR]

  From baseline to 1-year and 3-year

Other Outcomes (9)

• Change in the number of hospitalizations

  From baseline to 1-year and 3-year

• Change in the episodes of hypoglycemia

  From baseline to 1-year and 3-year

• Change in the scoring of Patient Health Questionnaire 9 (PHQ9)

  From baseline to 1-year and 3-year

Study Arms (2)

EMERALD

ACTIVE COMPARATOR

Patients will have 1-year multicomponent program (EMERALD) intervention including a total of 6 interactive workshops focusing on empowerment skills, healthy eating and exercise. Please refer to the protocol for further details.

Other: EMERALD intervention

Usual care

PLACEBO COMPARATOR

Usual management without any workshop or program

Other: Usual care

Interventions

EMERALD intervention OTHER

EMERALD consists of a 1-year multi-component structured program led by nurses and held 4-weekly for the first 3 months, followed by maintenance program, peers support and telephone calls.

EMERALD

Usual care OTHER

Usual care without any workshop or program

Usual care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetic patients
• Obesity as defined as body mass index (BMI) ³27 kg/m2 and/or waist circumference (WC) ³80cm in women and ³90cm in men
• Poor glycemic control as defined as HbA1c³8%
• Age between 18-70 years

You may not qualify if:

• Type 1 diabetes
• Active malignant disease (Patients with malignant disease who have been disease-free for at least 5 years are eligible)
• Life expectancy less than 12 months
• Any medical illness or condition as judged by the investigators as ineligible to participate the study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alice Kong, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: April 13, 2018
• Study Start: July 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)