Completed

mHealth-Based Lifestyle Intervention for Overweight/Obese Type 2 Diabetes Patients

Study Aim

This study aims to evaluate the effectiveness of a mobile health-based lifestyle intervention in reducing HbA1c levels and promoting weight loss in overweight or obese individuals with type 2 diabetes.

What is being tested

lifestyle intervention

Behavioral

Who is being recruted

Body Weight+10

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 18 to 65 Years

+18 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: October 2022

See protocol details

Summary

Principal SponsorNingbo No. 1 Hospital

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 7, 2022

Actual date on which the first participant was enrolled.

This study focuses on type 2 diabetes, a long-term condition that affects how the body processes glucose, a type of sugar. It's often linked with being overweight or obese, which is when a person has an excessive amount of body fat. The study aims to help the 90-95% of diabetes patients who have type 2 diabetes, a number that's expected to reach 700 million by 2045. The goal is to find effective ways to manage this condition and its associated weight issues, as they can significantly impact a person's health and quality of life. The study uses a technology called mHealth, which combines artificial intelligence and health care, to create a lifestyle intervention that could be an efficient and accessible way to prevent and treat type 2 diabetes in individuals who are overweight or obese. The study takes place at Ningbo First Hospital and uses a combination of online and offline methods. Participants will receive a lifestyle intervention designed to help manage their weight and blood sugar levels. The study measures the effectiveness of this intervention by tracking changes in HbA1c, a marker for average blood sugar levels, and weight. It also evaluates if the intervention improves other health indicators like body composition and exercise capacity. The ultimate goal is to find a strategy that can slow down or even reverse the progression of type 2 diabetes in overweight or obese individuals.

Official TitleThe Effect of mHealth-Based Lifestyle Intervention on Overweight or Obese Patients With Type 2 Diabetes: A Randomized Controlled Trial

NCT05561855

Principal SponsorNingbo No. 1 Hospital

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

8 inclusion criteria required to participate

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;

18-65 years old;

Show More Criteria

10 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ningbo First Hospital

Ningbo, ChinaOpen Ningbo First Hospital in Google Maps

CompletedOne Study Center