Clinical trial NCT03609463: Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes
Official title: Promoting Weight Loss and Stress Reduction in Overweight and Obese Patients With Type 2 Diabetes: a Feasibility Study of a Combination of a Small Change and Well-Being Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Overweight and Obesity
Keywords: diabetes
overweight
obesity
well-being
behavioral
small change
weight loss
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Overweight and obese patients with type 2 diabetes will be recruited at 2 different diabetes clinics. Physicians will screen every patient attending to each clinic during the enrollment period for the presence of main eligibility criteria. Those patients who appear to be eligible will be introduced to the study and referred to a researcher for a more in-depth screening evaluation. Eligible patients who are interested in participating in the study will be asked to sign the informed consent. Consecutive patients will be randomly assigned in a 1:1 ratio to an experimental group or a control group. During the first month, participants in the experimental group will receive a well-being promoting intervention in adjunction to the treatment as usual (TAU), while those in the control group will be asked to follow the TAU. In the following 3 months participants in both groups will receive the small change intervention in adjunction to the the TAU. All in person sessions of the intervention will take place in an office of both the 2 diabetes clinics involved. Data about psychological and clinical variables will be collected for each participant through questionnaires and interviews at baseline, at post-intervention, and at 6 and 12 months of follow-up. Participants' weight will be measured at each assessment point using a scale. Medical charts will be accessed to collect further data about physiological parameters, treatment received and medical history.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Feasibility (Recruitment)
timeFrame: Baseline
measure: Feasibility (Retention)
timeFrame: Through study completion, intended to be 16 months
measure: Feasibility (Acceptability of Intervention)
timeFrame: Post-intervention, intended to be 4 months
Secondary outcomes:
measure: Change in Psychological Distress
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
measure: Change in Psychological Distress and Well-Being
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
measure: Change in Psychological Well-Being
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
measure: % Weight Change
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Other outcomes:
measure: Change in the Prevalence of Psychosomatic Syndromes
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
measure: Change in Hemoglobin A1C
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
measure: Change in Abdominal Circumference
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
measure: Change in Physical Activity, Eating Habits, and Stress
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
measure: Change in Food-Related Behaviors
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
measure: Change in Motivation for Weight Loss
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
measure: Change in Health-Related Quality of Life
timeFrame: Baseline, post-intervention (intended to be 4 months), 6 months post-intervention, 12 months post-intervention
Locations:
city: Casalmaggiore
country: Italy
facility: Struttura Semplice di Endocrinologia e Metabolismo, Ospedale Oglio Po
state: Cremona
city: Cesena
country: Italy
facility: Servizio Endocrinologia e Diabetologia, Ospedale Bufalini
state: Forlì-Cesena
Study officials:
affiliation: University of Bologna
name: Chiara Rafanelli, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.