T2DM Intensity Lifestyle Intervention

NCT05561855 | Completed

• 1 other identifier: NBFH20220755
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This RCT study will evaluate the effect of a lifestyle intervention on overweight or obese patients with type 2 diabetes mellitus. The primary hypothesis is that the mHealth-based intensive lifestyle intervention is sufficient to achieve weight loss and maintain glycated hemoglobin control.

Conditions

Diabetes Mellitus, Type 2; Overweight or Obesity

Outcome Measures

Primary Outcomes (2)

• Weight change from baseline

  measured in kilograms (kg) and calculate the change percentage(%)

  at end of the 3-month intervention

• The change of HbA1c from baseline

  measured in percent (%)

  at end of the 3-month intervention

Secondary Outcomes (11)

• The change in body mass index (BMI) from baseline

  at end of the 3-month intervention

• The change of waist circumference from baseline

  at end of the 3-month intervention

• The change of waist-to-hip circumference ratio from baseline

  at end of the 3-month intervention

• The change of both systolic and diastolic blood pressures from baseline

  at end of the 3-month intervention

• The change of body fat percentage from baseline

  at end of the 3-month intervention

Study Arms (2)

lifestyle intervention

EXPERIMENTAL

1. Weight monitoring: Participants are required to record the weighting data in the WeChat official account at least once a week to lose 5% or more of their initial body weight in 3 months. 2. Goals record: At baseline, the participants need to complete a behavioral goals questionnaire. All these behaviors are then ranked for each participant based on an algorithm that determines the participants'self-reported necessity, self-efficacy, and estimated caloric deficit from performing that behavior. The top six goals are assigned to each participant with two for every 4-week cycle. 3. Exercise: The form is the combination of aerobic exercise (3d/w) and resistance exercise(2d/w). Each participant will be equipped with a Huami watch as a means of monitoring. 4. Health education: Participants are provided with T2DM-related knowledge. They can also contact the endocrinologist online and offline.

Behavioral: lifestyle intervention

usual-care control

NO INTERVENTION

Participants assigned to the control group will receive routine medical care and diabetes education, and be treated with hypoglycemic drugs under the guidance of endocrinologists according to the patient's condition and clinical treatment standards throughout their participation in the trial. After finishing the study, they will be offered healthy management as the participants in the multi-component lifestyle intervention group.

Interventions

lifestyle intervention BEHAVIORAL

During the 3-month lifestyle intervention period, the participants need to complete the weight monitoring, behavioral goal recording, diet and exercise recording, online course learning by using the WeChat official account module of "Weight Loss and Glucose Control".They will receive corresponding feedback and integral rewards every week, and receive monthly follow-ups to complete health education, goal review, motivational interview as well as collecting medication changes and blood glucose monitoring data.

lifestyle intervention

Eligibility Criteria

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

You may qualify if:

• Meet the WHO diagnostic criteria for type 2 diabetes;
• The duration of diabetes is less than 5 years;
• HbA1c was between 6.5-11% in recent 3 months;
• years old;
• kg/m2≤BMI#40kg/m2;
• Weight loss within the past 3 months did not exceed 5% of initial weight;
• Currently using a smartphone;
• Voluntary participation.

You may not qualify if:

• Pregnant or lactating woman, or planning a pregnancy within 6 months after recruitment;
• Uncontrolled hypertension (resting blood pressure ≥ 160/100mmHg);
• Treatment with insulin;
• Acute complications of diabetes (diabetic ketoacidosis, hyperosmolar state, infection. etc) have occurred within the past 3 months, or one or more severe chronic complications of diabetes have existed, such as severe cardiovascular or cerebrovascular pathology (angina pectoris, myocardial infarction, grade III-IV heart failure, severe arrhythmia, transient cerebral ischemic attack, stroke, etc.), massive proteinuria (urinary albumin/creatinine ratio ≥300 mg/g), and severe diabetic foot, severe neuropathy, blurred vision.
• Currently using weight-reducing products such as orlistat, or other medications that can significantly affect weight such as diuretics and hormones;
• Severe cardiovascular and cerebrovascular diseases, respiratory diseases, hepatic and renal insufficiency, malignant tumors and other chronic consumptive diseases, active infections, and surgical history involving important organs within 3 months;
• Contraindications to physical activity;
• The presence of mental or cognitive impairment;
• Current participation in other clinical trial projects;
• Having the same family member involved in the research.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead
• Peking University: collaborator

Study Sites (1)

Ningbo First Hospital

Ningbo, Zhejiang, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Li Li, Bachelor

  Ningbo No. 1 Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 30, 2022
• Study Start: October 7, 2022
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)