ObesityMWLNCT05769907
Protocol for a Feasibility of a Motivational Interviewing for Weight Loss in Adults
A study testing Intervention Group in people with Obesity, run by Hospital de Clinicas de Porto Alegre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Motivational to Weight Loss Version 1 (MWL v.1): Protocol for a Feasibility Single-arm, Open-label Clinical Trial of a Motivational Interviewing, Stages and Processes of Change-based Intervention for Weight Loss in Adults
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.
Read the detailed description
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.
In session one, sociodemographic and clinical information will be collected through a structured interview as well clinical assessment including the following scales: the stage of change to lose weight (S-Weight), symptoms of depression (PROMIS depression v. 8.1a, ), anxiety (PROMIS anxiety v.8.1a, ), psychosocial functioning (FAST ), binge eating (TCAP ), current food intake (24-hours food recall, ), and cognitive process used while losing weight (P-Weight ). In addition, the first session will collect information regarding the participant's body weight, body fat, free fat mass, and waist and hip circumference.
As participants will be in the precontemplation or contemplation stage of change at the beginning of the study, the goals of the first session will be: a) develop participant rapport; b) develop the discrepancy, that is, understand the distance between what the participant wants to change and the actions are taken; c) roll with resistance, that is, do not conflict during the dialogue; d) avoid the correction reflex, that is, avoid correcting something the interviewee says, even if it is technically incorrect or not plausible; e) valuing and validating the person, that is, emphasizing points in the participant's speech to increase their self-confidence; f) establish an agenda of issues to be deal with that are related to being overweight or obese. All these objectives remain in subsequent sessions. To accomplish those goals, the interviewer will use the MI process called "explore," which leads to the topic the participant wants to discuss. The interviewer will use strategies such as open questions, affirmations, reflections, abstracts, exploring discrepancies, informing with permission, explore values and objectives based on the participants' speech in order to elicit from the person their different motives for the desired change . Each session will be registered following the Session Registration Form .
From sessions two to seven, the sessions will take place online through the platform Teams, and the participant will answer the S-weight scale to identify the actual stage of change to lose weight at the beginning of each session. In case of the participant is in the precontemplation, contemplation or preparation phases, the goals in the session will be a) encourage the participant to talk about the reasons that favor him to change and not to change; b) focus on the positive motives to change; c) Increase the participants' confidence, that is, explain that the style of this approach takes into account their autonomy, and thus, any and all decision-making will be shared and not directed from the interviewer to he/she, also because a basic premise of MI is that people are experts on themselves; d) extract from the participant how he/she could make the change, anticipating what it would be like if he/she had already made the change; e) show options for the participant to choose from, based on their own answers; f) stimulate through questions and reflections that the participant himself talks about his/her abilities, this increases the confidence that he is capable of doing things; g) prepare the participant for the action phase; h) predict difficulties; and i) prevent relapse. However, if the participant is in the action, maintenance, or relapse phase, the goals will be to a) stimulate the participant to develop solutions to promote autonomy and confidence in the decision-making process; b) reinforce the commitment to change; c) recall the participants' values through reflections; d) validate the actions already taken, even if they are damage reductions; e) support self-confidence; f) increase support network; g) prevent relapse; and h) consolidate the gains from the changes made.
The goals established in sessions two to seven will be pursued by the interviewer by using the MI process "focus," "evoke," and "plan". Focus will direct the conversation toward the possibility of change, creating a discrepancy between the participants' current actions and their broader life goals and values . Evoking will stimulate the participant to talk about their motivations for change. Planning includes helping the participant to identify a goal, building an action plan, and anticipating difficulties. The interviewer will use strategies such as closed questions, open questions, reflection, importance rule, and trust ruler.
In the last session, the participant will attend an in-person session for the measurement of body weight, body fat, free fat mass, waist, and hip circumference, as well as the assessment of the same clinical scales used in the first session). In addition, the participant will fill in a questionnaire regarding the interviewer's attitude during the sessions, which will indicate the compliance of the researcher with the MI approach.
- Conditions
- Obesity
- Being tested
- Intervention Group
- Keywords
- Obesity, Transtheoretical Model, P-Weight, S-Weight, Change talk, Motivational interviewing
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to test the feasibility and acceptability of the pilot study
Adherence rate, Recruitment rate, Retention rates
Measured: 8 weeks
Secondary outcomes (2)
percentage of weight loss body
5% of baseline
Measured: 8 weeks
number of participants who progressed through stages of change in weight loss
70% of participants progress through the change stage
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 .
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriane Ribeiro Rosa, Hospital de Clinicas de Porto Alegre
- Investigators
- Quênia de Carvalho, Author, Principal investigator, HC Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769907
- Sponsor's protocol ID
- 20220209
- Other IDs
- 59573622300005327
- Acronym
- MWL
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burgess E, Hassmen P, Welvaert M, Pumpa KL. Behavioural treatment strategies improve adherence to lifestyle intervention programmes in adults with obesity: a systematic review and meta-analysis. Clin Obes. 2017 Apr;7(2):105-114. doi: 10.1111/cob.12180. Epub 2017 Feb 15.
PubMed 28199047de Freitas PP, de Menezes MC, Dos Santos LC, Pimenta AM, Ferreira AVM, Lopes ACS. The transtheoretical model is an effective weight management intervention: a randomized controlled trial. BMC Public Health. 2020 May 11;20(1):652. doi: 10.1186/s12889-020-08796-1.
PubMed 32393214Di Noia J, Prochaska JO. Dietary stages of change and decisional balance: a meta-analytic review. Am J Health Behav. 2010 Sep-Oct;34(5):618-32. doi: 10.5993/ajhb.34.5.11.
PubMed 20524891Hayotte M, Negre V, Gray L, Sadoul JL, d'Arripe-Longueville F. The transtheoretical model (TTM) to gain insight into young women's long-term physical activity after bariatric surgery: a qualitative study. Obes Surg. 2020 Feb;30(2):595-602. doi: 10.1007/s11695-019-04220-9.
PubMed 31654341Karintrakul S, Angkatavanich J. A randomized controlled trial of an individualized nutrition counseling program matched with a transtheoretical model for overweight and obese females in Thailand. Nutr Res Pract. 2017 Aug;11(4):319-326. doi: 10.4162/nrp.2017.11.4.319. Epub 2017 Jun 22.
PubMed 28765778Tanikawa Y, Kimachi M, Ishikawa M, Hisada T, Fukuhara S, Yamamoto Y. Association between work schedules and motivation for lifestyle change in workers with overweight or obesity: a cross-sectional study in Japan. BMJ Open. 2020 Apr 30;10(4):e033000. doi: 10.1136/bmjopen-2019-033000.
PubMed 32354776Hardcastle SJ, Taylor AH, Bailey MP, Harley RA, Hagger MS. Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention follow-up. Int J Behav Nutr Phys Act. 2013 Mar 28;10:40. doi: 10.1186/1479-5868-10-40.
PubMed 23537492Ismail K, Stahl D, Bayley A, Twist K, Stewart K, Ridge K, Britneff E, Ashworth M, de Zoysa N, Rundle J, Cook D, Whincup P, Treasure J, McCrone P, Greenough A, Winkley K. Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT. Health Technol Assess. 2019 Dec;23(69):1-144. doi: 10.3310/hta23690.
PubMed 31858966Moss EL, Tobin LN, Campbell TS, von Ranson KM. Behavioral weight-loss treatment plus motivational interviewing versus attention control: lessons learned from a randomized controlled trial. Trials. 2017 Jul 25;18(1):351. doi: 10.1186/s13063-017-2094-1.
PubMed 28743313Suire KB, Kavookjian J, Feiss R, Wadsworth DD. Motivational Interviewing for Weight Management Among Women: a Meta-Analysis and Systematic Review of RCTs. Int J Behav Med. 2021 Aug;28(4):403-416. doi: 10.1007/s12529-020-09934-0. Epub 2020 Oct 20.
PubMed 33083891Makin H, Chisholm A, Fallon V, Goodwin L. Use of motivational interviewing in behavioural interventions among adults with obesity: A systematic review and meta-analysis. Clin Obes. 2021 Aug;11(4):e12457. doi: 10.1111/cob.12457. Epub 2021 May 6.
PubMed 33955152Toral N, Slater B. [Transtheoretical model approach in eating behavior]. Cien Saude Colet. 2007 Nov-Dec;12(6):1641-50. doi: 10.1590/s1413-81232007000600025. Portuguese.
PubMed 18813500Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957Andres A, Saldana C, Gomez-Benito J. Establishing the stages and processes of change for weight loss by consensus of experts. Obesity (Silver Spring). 2009 Sep;17(9):1717-23. doi: 10.1038/oby.2009.100. Epub 2009 Apr 9.
PubMed 19360014Duran Aguero S, Araneda J, Ahumada D, Silva Rojas J, Bonacich RB, Caichac A, Salamanca MF, Villarroel P, Fernandez E, Pacheco V, Martinovic PA, Wilson W, Neira AM, Encina C, Tilleria JM. A Multicenter Study Evaluating the Stages of Change in Food Consumption with Warning Labels among Chilean University Students. Biomed Res Int. 2020 Jan 16;2020:2317929. doi: 10.1155/2020/2317929. eCollection 2020.
PubMed 32461968
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational to Weight Loss Version 1 (MWL v.1): Protocol for a Feasibility Single-arm, Open-label Clinical Trial of a Motivational Interviewing, Stages and Processes of Change-based Intervention for Weight Loss in Adults
- ClinicalTrials.gov ID
- NCT05769907
- Acronym / sponsor ID
- MWL / 20220209
- Conditions
- Obesity
- Keywords
- Obesity, Transtheoretical Model, P-Weight, S-Weight, Change talk, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
In session one, sociodemographic and clinical information will be collected through a structured interview as well clinical assessment including the following scales: the stage of change to lose weight (S-Weight), symptoms of depression (PROMIS depression v. 8.1a, ), anxiety (PROMIS anxiety v.8.1a, ), psychosocial functioning (FAST ), binge eating (TCAP ), current food intake (24-hours food recall, ), and cognitive process used while losing weight (P-Weight ). In addition, the first session will collect information regarding the participant's body weight, body fat, free fat mass, and waist and hip circumference.
As participants will be in the precontemplation or contemplation stage of change at the beginning of the study, the goals of the first session will be: a) develop participant rapport; b) develop the discrepancy, that is, understand the distance between what the participant wants to change and the actions are taken; c) roll with resistance, that is, do not conflict during the dialogue; d) avoid the correction reflex, that is, avoid correcting something the interviewee says, even if it is technically incorrect or not plausible; e) valuing and validating the person, that is, emphasizing points in the participant's speech to increase their self-confidence; f) establish an agenda of issues to be deal with that are related to being overweight or obese. All these objectives remain in subsequent sessions. To accomplish those goals, the interviewer will use the MI process called "explore," which leads to the topic the participant wants to discuss. The interviewer will use strategies such as open questions, affirmations, reflections, abstracts, exploring discrepancies, informing with permission, explore values and objectives based on the participants' speech in order to elicit from the person their different motives for the desired change . Each session will be registered following the Session Registration Form .
From sessions two to seven, the sessions will take place online through the platform Teams, and the participant will answer the S-weight scale to identify the actual stage of change to lose weight at the beginning of each session. In case of the participant is in the precontemplation, contemplation or preparation phases, the goals in the session will be a) encourage the participant to talk about the reasons that favor him to change and not to change; b) focus on the positive motives to change; c) Increase the participants' confidence, that is, explain that the style of this approach takes into account their autonomy, and thus, any and all decision-making will be shared and not directed from the interviewer to he/she, also because a basic premise of MI is that people are experts on themselves; d) extract from the participant how he/she could make the change, anticipating what it would be like if he/she had already made the change; e) show options for the participant to choose from, based on their own answers; f) stimulate through questions and reflections that the participant himself talks about his/her abilities, this increases the confidence that he is capable of doing things; g) prepare the participant for the action phase; h) predict difficulties; and i) prevent relapse. However, if the participant is in the action, maintenance, or relapse phase, the goals will be to a) stimulate the participant to develop solutions to promote autonomy and confidence in the decision-making process; b) reinforce the commitment to change; c) recall the participants' values through reflections; d) validate the actions already taken, even if they are damage reductions; e) support self-confidence; f) increase support network; g) prevent relapse; and h) consolidate the gains from the changes made.
The goals established in sessions two to seven will be pursued by the interviewer by using the MI process "focus," "evoke," and "plan". Focus will direct the conversation toward the possibility of change, creating a discrepancy between the participants' current actions and their broader life goals and values . Evoking will stimulate the participant to talk about their motivations for change. Planning includes helping the participant to identify a goal, building an action plan, and anticipating difficulties. The interviewer will use strategies such as closed questions, open questions, reflection, importance rule, and trust ruler.
In the last session, the participant will attend an in-person session for the measurement of body weight, body fat, free fat mass, waist, and hip circumference, as well as the assessment of the same clinical scales used in the first session). In addition, the participant will fill in a questionnaire regarding the interviewer's attitude during the sessions, which will indicate the compliance of the researcher with the MI approach.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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 .
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Behavioral: Intervention GroupThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThe 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. | Behavioural | single arm |
Primary outcome
The primary outcome is to test the feasibility and acceptability of the pilot study
Time frame: 8 weeks
Adherence rate, Recruitment rate, Retention rates
2 secondary outcomes
percentage of weight loss body
Time frame: 8 weeks
number of participants who progressed through stages of change in weight loss
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Background: PubMed 28199047Burgess E, Hassmen P, Welvaert M, Pumpa KL. Behavioural treatment strategies improve adherence to lifestyle intervention programmes in adults with obesity: a systematic review and meta-analysis. Clin Obes. 2017 Apr;7(2):105-114. doi: 10.1111/cob.12180. Epub 2017 Feb 15.
- Background: PubMed 32393214de Freitas PP, de Menezes MC, Dos Santos LC, Pimenta AM, Ferreira AVM, Lopes ACS. The transtheoretical model is an effective weight management intervention: a randomized controlled trial. BMC Public Health. 2020 May 11;20(1):652. doi: 10.1186/s12889-020-08796-1.
- Background: PubMed 20524891Di Noia J, Prochaska JO. Dietary stages of change and decisional balance: a meta-analytic review. Am J Health Behav. 2010 Sep-Oct;34(5):618-32. doi: 10.5993/ajhb.34.5.11.
- Background: PubMed 31654341Hayotte M, Negre V, Gray L, Sadoul JL, d'Arripe-Longueville F. The transtheoretical model (TTM) to gain insight into young women's long-term physical activity after bariatric surgery: a qualitative study. Obes Surg. 2020 Feb;30(2):595-602. doi: 10.1007/s11695-019-04220-9.
- Background: PubMed 28765778Karintrakul S, Angkatavanich J. A randomized controlled trial of an individualized nutrition counseling program matched with a transtheoretical model for overweight and obese females in Thailand. Nutr Res Pract. 2017 Aug;11(4):319-326. doi: 10.4162/nrp.2017.11.4.319. Epub 2017 Jun 22.
- Background: PubMed 32354776Tanikawa Y, Kimachi M, Ishikawa M, Hisada T, Fukuhara S, Yamamoto Y. Association between work schedules and motivation for lifestyle change in workers with overweight or obesity: a cross-sectional study in Japan. BMJ Open. 2020 Apr 30;10(4):e033000. doi: 10.1136/bmjopen-2019-033000.
- Background: PubMed 23537492Hardcastle SJ, Taylor AH, Bailey MP, Harley RA, Hagger MS. Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention follow-up. Int J Behav Nutr Phys Act. 2013 Mar 28;10:40. doi: 10.1186/1479-5868-10-40.
- Background: PubMed 31858966Ismail K, Stahl D, Bayley A, Twist K, Stewart K, Ridge K, Britneff E, Ashworth M, de Zoysa N, Rundle J, Cook D, Whincup P, Treasure J, McCrone P, Greenough A, Winkley K. Enhanced motivational interviewing for reducing weight and increasing physical activity in adults with high cardiovascular risk: the MOVE IT three-arm RCT. Health Technol Assess. 2019 Dec;23(69):1-144. doi: 10.3310/hta23690.
- Background: PubMed 28743313Moss EL, Tobin LN, Campbell TS, von Ranson KM. Behavioral weight-loss treatment plus motivational interviewing versus attention control: lessons learned from a randomized controlled trial. Trials. 2017 Jul 25;18(1):351. doi: 10.1186/s13063-017-2094-1.
- Background: PubMed 33083891Suire KB, Kavookjian J, Feiss R, Wadsworth DD. Motivational Interviewing for Weight Management Among Women: a Meta-Analysis and Systematic Review of RCTs. Int J Behav Med. 2021 Aug;28(4):403-416. doi: 10.1007/s12529-020-09934-0. Epub 2020 Oct 20.
- Background: PubMed 33955152Makin H, Chisholm A, Fallon V, Goodwin L. Use of motivational interviewing in behavioural interventions among adults with obesity: A systematic review and meta-analysis. Clin Obes. 2021 Aug;11(4):e12457. doi: 10.1111/cob.12457. Epub 2021 May 6.
- Background: PubMed 18813500Toral N, Slater B. [Transtheoretical model approach in eating behavior]. Cien Saude Colet. 2007 Nov-Dec;12(6):1641-50. doi: 10.1590/s1413-81232007000600025. Portuguese.
- PSS Health: Power and Sample Size for Health Researchers \[Internet\]. \[cited 11 de fevereiro de 2021\]Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quênia de Carvalho, Author principal investigator
HC Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Obesity, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriane R Rosa, Corresponding author (+55 (51) 3359.6328, adrianerrosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is to test the feasibility and acceptability of the pilot study (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05769907, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.