Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients

NCT07045272 | Not Yet Recruiting

• 1 other identifier: WDanni
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study applied digital technology to a comprehensive lifestyle intervention strategy to design a digital behavioural intervention programme suitable for weight reduction in overweight obese infertile patients in China, and assessed its intervention effect through a randomised controlled trial.The main questions it aims to answer are: 1\) Design and implement a digital behavioural weight loss intervention programme; 2) Evaluate the impact of digital behavioural interventions on weight loss outcomes and health outcomes. Participants will be randomly assigned to a control group and an intervention group. The control group will receive only routine health education and the intervention group will receive an 8-week digital behavioural intervention. At the end of the intervention, the follow-up period will be one year for reproductive outcomes.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (3)

• Weight change

  From enrollment to the end of treatment at 8 weeks

• Number of oocytes retrieved

  up to 16weeks

• Number of embryos available for transfer

  up to 17 weeks

Secondary Outcomes (4)

• Percentage of weight loss

  From enrollment to the end of treatment at 8 weeks

• Body fat content and distribution

  From enrollment to the end of treatment at 8 weeks

• live birth rate

  2 years

• Pregnancy rate

  up to 1 year

Study Arms (2)

digital behavioral intervention

EXPERIMENTAL

A comprehensive intervention program that combines digital technologies，Including interventions for diet, exercise, mood, sleep, etc.

Behavioral: Experimental

Regular Education Group

NO INTERVENTION

Physicians provided only their standard verbal counseling during clinic visits, without any additional interventions.

Interventions

Experimental BEHAVIORAL

The intervention team provides lifestyle guidance to the subjects according to the behavioural intervention programme, and the subjects record information on diet, exercise and weight on the platform on a daily basis. Subjects are required to learn relevant health education knowledge on the platform by themselves, and they can also exchange experience in the group and receive motivational counselling from the instructors.

digital behavioral intervention

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Fulfilling the World Health Organization diagnostic criteria for infertility, defined as failure to achieve or sustain a clinical pregnancy after ≥1 year of regular unprotected sexual intercourse among couples of reproductive age;
• patients aged 20-40 years seeking assisted reproductive technology (ART) treatment;
• Body mass index (BMI) \>=24 kg/m²;
• Willingness to undergo randomization;
• Absence of significant comorbidities (e.g., uncontrolled hypertension, diabetes mellitus, malignancies);
• Commitment to participate in and complete the intervention protocol.

You may not qualify if:

• History of major systemic diseases (e.g., cardiovascular disorders, chronic respiratory diseases) or psychiatric disorders (e.g., schizophrenia, major depressive disorder);
• Current or prior participation in other clinical trials within the past 3 months;
• Medical contraindications to physical exercise (e.g., severe osteoarthritis, uncontrolled arrhythmias);
• Previous weight-loss interventions, including pharmacological therapy (e.g., orlistat, liraglutide) or bariatric surgery.

Sponsors & Collaborators

• Anhui Medical University: lead

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 1, 2025
• Study Start: July 10, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share