Protocol for a Feasibility of a Motivational Interviewing for Weight Loss in Adults

NCT05769907 | Unknown

• 2 other identifiers: 2022020959573622300005327
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

Abstract Introduction: This pilot study will determine the recruitment feasibility, retention, and adhesion for a motivational interviewing program for weight loss in adults according to the processes of change in weight loss. Methods and Analysis: The single-arm pilot study will be a feasibility study of the Motivation to Lose Weight version 1 (MLW v.1). The study includes presential and online sessions. Participants will be recruited through advertisements on social media and selected according to the inclusion criteria. Participants will receive 8 sessions of approximately 30-45 minutes of motivational interviewing (MI) according to the processes of change in weight loss, as measured by the S-Weight scale. The results will be evaluated at the beginning and the end of the program, which will last 8 weeks. The primary outcome of the study is feasibility. The intervention will be feasible if adherence to the proposed activities in the sessions is greater than 70%, we can recruit 10 patients within 8 weeks, the proportion of interested people and registered participants is greater than 30%, and more than 75% of participants attend the final study visit. The secondary outcome is weight loss, fat mass percentage, muscle mass, waist and hip measurements, and the scores of behavioral scales. Ethics and discussion: The feasibility of this project consists of proposing an individualized intervention based on MI strategy(s) for each participant, according to the stage of readiness, and thus, help to evolve in the process of losing weight. This intervention aims to increase the participant's confidence level to implement actions that lead to the progression of behavior and, consequently, the action and maintenance of the lost weight. This study was approved by the Research Ethics Committee (REC) of the Hospital de Clínicas de Porto Alegre (HCPA) under number 20220209 CAAE 59573622300005327.

Conditions

Obesity

Keywords

Obesity; Transtheoretical Model; P-Weight; S-Weight; Change talk; Motivational interviewing

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to test the feasibility and acceptability of the pilot study

  Adherence rate, Recruitment rate, Retention rates

  8 weeks

Secondary Outcomes (2)

• percentage of weight loss body

  8 weeks

• number of participants who progressed through stages of change in weight loss

  8 weeks

Study Arms (1)

single arm

EXPERIMENTAL

The single-arm pilot study will be a feasibility study of the Motivation to Lose Weight version 1 (MLW v.1). The study includes presential and online sessions. Participants will be recruited through advertisements on social media and selected according to the inclusion criteria. Participants will receive 8 sessions of approximately 30-45 minutes of motivational interviewing (MI) according to the processes of change in weight loss, as measured by the S-Weight scale.

Behavioral: Intervention Group

Interventions

Intervention Group BEHAVIORAL

The study will consist of one session per week for 8 weeks, during which the participant will receive MI for 30-45 minutes. All participants will receive the MI intervention according to their readiness to lose weight measured by means the P-weight and S-weight at the beginning of each session.

single arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: people over 18 and under 60
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-60; BMI from 25-34.90 (Kg/m²); Residents of Porto Alegre and nearby regions; No weight loss treatment in the last 6 months; Pre-contemplation or contemplation phase for changing body weight when responding to the S-Weight scale; Stable body weight in the last 3 months (\<2% loss); Access to Teams platform; Have access to a body weight scale.

You may not qualify if:

• Major surgery in the last 3 months; Diagnosed eating disorder; Use of mood stabilizer drugs or antipsychotics, antiobesity or adjuvants in weight control, as well as corticoids (prednisone and similar) in doses greater than 10 mg per day; Dietary treatment for weight loss in the last 6 months; Myocardial infarction or angioplasty in the last 3 months, with chronic kidney disease or undergoing dialysis; with chronic liver failure (Ascites), with congestive heart failure, undergoing treatment for cancer or with the Human Immunodeficiency Virus (HIV); Pregnant and lactating women.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

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Related Links

• PSS Health: Power and Sample Size for Health Researchers \[Internet\]. \[cited 11 de fevereiro de 2021\]

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Quênia de Carvalho, Author

  HC Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriane R Rosa, Corresponding author

CONTACT

+55 (51) 3359.6328; adrianerrosa@gmail.com

Quênia Carvalho, Author

CONTACT

5191236601; carvalhoquenia@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Study setting The study was carried on by the Laboratory of Molecular Psychiatry at Hospital Clinic of Porto Alegre (HCPA), Brazil. The study will consist of face-to-face sessions performed in the Clinical Research Center (CPC) of the HCPA and online sessions performed through the platform Teams. This project complies with the guidelines presented in SPIRIT 2013 "Standard protocol items: Recommendations for Interventional Trials," an international protocol that aims to improve the completeness of studies, producing recommendations for a minimum set of items to be addressed. The 2013 SPIRIT Statement includes a 33-item checklist .

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: August 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: March 30, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share