Nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry

Completed

• Conditions: Obesity due to excess calories,

• Registration Number: CTRI/2021/12/038785
• Lead Sponsor: JIPMER Intra Mural Research Fund

Brief Summary

This is randomized trial to evaluate the effectiveness of  nurse-led intervention on weight reduction among adults with obesity in urban areas of Puducherry. 

Report of the Pilot Study:

The recent increase in type 2 diabetes is likely due to the rising prevalence of overweight and obesity, which heightens the risk of non-communicable diseases. This study aimed to evaluate the effectiveness of nurse-led intervention (NLI) strategies on weight reduction among adults in urban Puducherry. A two-arm, parallel-group, randomized controlled study was conducted with 88 obese adults from Nesavalar colony and Govindanpet between November 2022 and February 2023. Participants were randomized into either the NLI or general care (GC) arm. Interviews were conducted to gather demographic and behavioral risk factor data, and physical and biochemical measurements were taken following standardized procedures. Villages were randomly assigned to either the intervention or control group using Excel. The NLI group received nurse-led interventions, including Surya Namaskar yoga, while the GC group received standard care. At 16 weeks, the NLI arm showed a significant mean weight loss of -2.58 kg, compared to a 0.38 kg gain in the GC arm, with improvements in waist circumference, body mass index, cholesterol profile, and thyroid-stimulating hormone levels. The study demonstrated that nurse-led interventions effectively reduced weight and the risk of non-communicable diseases in urban Puducherry, though a more extensive follow-up plan and additional manpower will be necessary for larger studies.

Summary of the Main Study:

Participants were interviewed to gather demographic information and assess behavioral risk factors, including diet and physical activity. Physical measurements such as height, weight, waist circumference, and blood pressure were taken following standardized procedures. Biochemical measurements involved blood sample collection after overnight fasting to analyze fasting blood glucose, total cholesterol, and thyroid profile. Villages were randomly assigned to either the intervention or control group using Excel, ensuring equal distribution. No allocation concealment was used since the intervention was applied simultaneously across villages, reducing selection bias. Blinding was not implemented due to the primary investigator’s involvement in both intervention delivery and baseline assessments; however, outcome assessments were conducted by independent nurses who were blinded to group assignments. The intervention group received nurse-led interventions, including sessions on Surya Namaskar (Sun Salutation) yoga, while the control group received standard care. After 12 months, participants’ weight reduction was reassessed and compared with baseline data, and health workers in the control group were subsequently educated using the nurse-led intervention package. COVID-19 precautions were implemented to prevent transmission, particularly in containment zones.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-06
• Study Completion: 2024-02-29
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 438

Inclusion Criteria

Adults with obesity, aged between 18-50 yrs, all gender,who can speak and write Tamil or English,who access to phone.

Exclusion Criteria

• Adults with limitations for physical activities (physical disability and bed ridden), with medications and diseases, which can affect weight loss, currently on weight loss program, bariatric surgery and pregnant, visual and hearing impairments.
• •Psychiatric disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinically significant reduction in body weight ≥ 5% from baseline weight among intervention group compared with general care group.	Baseline assessment- at 1st month | Midline assessment-at 6th month | Endline assessment-at 12th month

Secondary Outcome Measures

Name	Time	Method
Proportion of beneficial effect among nurse-led intervention group	1.Reduction in absolute weight.

Trial Locations

Locations (1)

Urban areas of Puducherry.; 🇮🇳 Pondicherry, PONDICHERRY, India

Urban areas of Puducherry.

🇮🇳Pondicherry, PONDICHERRY, India

Dr M J Kumari

Principal investigator

9894595420

kumari_mj@ymail.com