Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes

NCT03609463 | Completed

• 1 other identifier: PWLPWB-CVD
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

Brief Summary

This is a feasibility and acceptability study of a 16-month single-blind randomized controlled trial (RCT) designed to test the initial effectiveness of a well-being and small lifestyle changes intervention aimed at promoting weight loss and stress reduction in overweight and obese patients with type 2 diabetes. Primary goals of this study are to 1) evaluate study feasibility and patient acceptability, 2) develop a tailored protocol of a behavioral intervention for overweight or obese patients with type 2 diabetes that takes stress and well-being into consideration, 3) evaluate appropriateness of research procedures and measures, 4) examine effect size estimates of key outcomes to provide essential data to inform a larger efficacy trial, 5) determine whether clinically significant improvements occurred in any key outcomes.

Conditions

Diabetes Mellitus, Type 2; Overweight and Obesity

Keywords

diabetes; overweight; obesity; well-being; behavioral; small change; weight loss

Outcome Measures

Primary Outcomes (3)

• Feasibility (Recruitment)

  Measured as the acceptance rate (total number of participants enrolled out of the total number of eligible candidates approached).

  Baseline

• Feasibility (Retention)

  Measured as drop-out rates (total number of participants who withdraw out of the total number enrolled).

  Through study completion, intended to be 16 months

• Feasibility (Acceptability of Intervention)

  Measured as total number of sessions attended and number of weeks needed to complete the intervention. Semi-structured interviews will be conducted to estimate patients' satisfaction and provide data on optimal timing, dosing, and delivery.

  Post-intervention, intended to be 4 months

Secondary Outcomes (4)

• Change in Psychological Distress

  Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

• Change in Psychological Distress and Well-Being

  Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

• Change in Psychological Well-Being

  Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

• % Weight Change

  Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

Other Outcomes (7)

• Change in the Prevalence of Psychosomatic Syndromes

  Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

• Change in Hemoglobin A1C

  Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

• Change in Abdominal Circumference

  Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention

Study Arms (2)

Well-being and small change

EXPERIMENTAL

Participants will be randomized to receive 4 individual 1-hour weekly sessions of the well-being intervention before starting the 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.

Behavioral: Small change intervention; Behavioral: Well-being intervention; Other: Treatment as usual

Small change

ACTIVE COMPARATOR

Participants will be randomized to receive 12 individual 1-hour weekly sessions of the small change intervention in addition to the treatment as usual.

Behavioral: Small change intervention; Other: Treatment as usual

Interventions

Small change intervention BEHAVIORAL

The small change intervention is a behavioral intervention to help people gradually lose weight by making small changes in their lifestyle. At the beginning of the intervention participants will be met in person to be guided in setting an eating and a physical activity goal. Participants will be then contacted through the phone or met in person weekly for 3 months to check on their adherence to the selected goals and to discuss about facilitators and barriers to goal completion, in order to increase their motivation and problem solving skills. Every weekly contact will last about an hour and will be administered in an individual setting. At each contact selected goals can be revised, changed or another goal can be added based on levels of adherence.

Small change; Well-being and small change

Well-being intervention BEHAVIORAL

The well-being intervention is a coaching intervention aimed at motivating people in making lifestyle changes by reducing levels of stress through the promotion of psychological well-being. It will consists in 4 weekly sessions to be held before starting the small change intervention. Each session will last about an hour and will be administered in an individual setting.

Well-being and small change

Treatment as usual OTHER

The treatment as usual includes any recommendation given to the participants by their physicians, including diet, physical activity, medication and glycemic control instructions.

Small change; Well-being and small change

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥ 25;
• Age ≥ 18;
• Diagnosis of type 2 diabetes;
• Fluent English or Italian.

You may not qualify if:

• Inability to provide informed consent to participate in the study for any reason, including cognitive impairment and psychiatric illness;
• Presence of any medical condition that would make participation in the study difficult and/or unsafe;
• Presence of any medical condition associated with unintentional weight loss or gain;
• Presence of untreated, severe and/or recently diagnosed (≤ 6 months) mental illness and/or presence of a severe personality disorder;
• History of eating disorders and/or substance abuse;
• Use of drugs for weight loss;
• Participation in another weight loss program or in any other trial;
• Participation in an individual or group psychological intervention;
• Weight loss surgery within the year;
• Pregnant or are planning to become pregnant within the year
• Inability to control meal contents (e.g. institutionalized patients).

Sponsors & Collaborators

• Chiara Rafanelli: lead

Study Sites (2)

Struttura Semplice di Endocrinologia e Metabolismo, Ospedale Oglio Po

Casalmaggiore, Cremona, 26041, Italy

Location

Servizio Endocrinologia e Diabetologia, Ospedale Bufalini

Cesena, Forlì-Cesena, 47521, Italy

Location

Related Publications (7)

• Hill JO. Can a small-changes approach help address the obesity epidemic? A report of the Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council. Am J Clin Nutr. 2009 Feb;89(2):477-84. doi: 10.3945/ajcn.2008.26566. Epub 2008 Dec 16.

  PMID: 19088151 BACKGROUND

• Phillips-Caesar EG, Winston G, Peterson JC, Wansink B, Devine CM, Kanna B, Michelin W, Wethington E, Wells M, Hollenberg J, Charlson ME. Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE. Contemp Clin Trials. 2015 Mar;41:118-28. doi: 10.1016/j.cct.2015.01.003. Epub 2015 Jan 26.

  PMID: 25633208 BACKGROUND

• Phillips EG, Wells MT, Winston G, Ramos R, Devine CM, Wethington E, Peterson JC, Wansink B, Charlson M. Innovative approaches to weight loss in a high-risk population: The small changes and lasting effects (SCALE) trial. Obesity (Silver Spring). 2017 May;25(5):833-841. doi: 10.1002/oby.21780. Epub 2017 Apr 5.

  PMID: 28382755 BACKGROUND

• Geiker NRW, Astrup A, Hjorth MF, Sjodin A, Pijls L, Markus CR. Does stress influence sleep patterns, food intake, weight gain, abdominal obesity and weight loss interventions and vice versa? Obes Rev. 2018 Jan;19(1):81-97. doi: 10.1111/obr.12603. Epub 2017 Aug 28.

  PMID: 28849612 BACKGROUND

• Fava GA. Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5. No abstract available.

  PMID: 27043240 BACKGROUND

• Ryff CD. Psychological well-being revisited: advances in the science and practice of eudaimonia. Psychother Psychosom. 2014;83(1):10-28. doi: 10.1159/000353263. Epub 2013 Nov 19.

  PMID: 24281296 BACKGROUND

• Benasi G, Gostoli S, Zhu B, Offidani E, Artin MG, Gagliardi L, Rignanese G, Sassi G, Fava GA, Rafanelli C. Well-Being Therapy and Lifestyle Intervention in Type 2 Diabetes: A Pilot Randomized Controlled Trial. Psychosom Med. 2022 Nov-Dec 01;84(9):1041-1049. doi: 10.1097/PSY.0000000000001115. Epub 2022 Aug 2.

  PMID: 36346956 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Diabetes Mellitus; Behavior; Weight Loss

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Chiara Rafanelli, MD, PhD

  University of Bologna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A researcher adequately trained in the administration of questionnaires and interviews, and blinded to the experimental allocation of patients, will carry out all the evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 1, 2018
• Study Start: March 27, 2018
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)