Integrating Small Changes and Positive Psychology to Improve Treatment Readiness: A Weight Loss Trial

NCT04487158 | Unknown

• 1 other identifier: H19-02665
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to compare short- and long-term changes in body weight (kg) and subjective well-being in adult females with obesity who have been randomized to receive one of two 6-month treatment conditions: INSPIRE or Small Changes. The Small Changes approach is an evidence-based behavioural weight management program that uses relative and modest changes in nutrition and physical activity to produce a caloric deficit. The INSPIRE program is a modification of the Small Changes program that spends the first four weeks on improving well-being via psychological interventions.

Conditions

Obesity

Keywords

Behavioral Intervention; Psychological Intervention; Weight Management

Outcome Measures

Primary Outcomes (4)

• Change from baseline weight (self-report)

  (kg)

  3 months

• Change from baseline weight (self-report)

  (kg)

  6 months

• Change from baseline weight

  (kg)

  9 months

• Change from baseline weight

  (kg)

  12 months

Secondary Outcomes (6)

• Change from Baseline on the Satisfaction with Life Scale

  3 months

• Change from Baseline on the Satisfaction with Life Scale

  6 months

• Change from Baseline on the Satisfaction with Life Scale

  12 months

• Change from Baseline on the Scale of Positive and Negative Experiences

  3 months

• Change from Baseline on the Scale of Positive and Negative Experiences (SPANE)

  6 months

Other Outcomes (30)

• Change from Baseline in Waist Circumference

  9 months

• Change from Baseline in Waist Circumference

  12 months

• Change from Baseline in Blood Pressure

  9 months

Study Arms (2)

Small Changes

ACTIVE COMPARATOR

Behavioral: Small Changes

INSPIRE

EXPERIMENTAL

Behavioral: INSPIRE

Interventions

Small Changes BEHAVIORAL

The Small Changes program is an evidence-based 6-month weight-management program. The program runs weekly for 3 months followed by by-weekly contact for 3-months (1x in-person group and 1x phone call). This program uses behaviour change strategies to help with weight loss. The Small Changes approach is different from traditional dieting programs because it encourages modest changes to diet and physical activity which are not overly taxing to maintain. Participants are asked to reduce their nutritional intake by 200-400 calories per day. You will also be asked to increase their daily step count by 2000-3000 steps. Weekly intervention topics include: Monitoring, Nutrition, Physical Activity, Breaking the Chain, External Cues, Mindful Eating, Body Image, Stress, Sleep, Social Support, Social Eating, and the Stoplight Guide.

Small Changes

INSPIRE BEHAVIORAL

The INSPIRE program is a modification to the Small Changes program. It combines elements of positive psychology and behaviour change to help with weight loss. The first four weeks of the program are oriented towards improving well-being and include topics such as values, self-compassion/mindfulness, character strengths, and gratitude. The remaining 8 weeks mirrors the Small Changes program in making modest changes to diet and physical activity to achieve weight loss. Participants are asked to reduce their nutritional intake by 200-400 calories per day. Participants will also be asked to increase their daily step count by 2000-3000 steps.

INSPIRE

Eligibility Criteria

• Age: 25 Years - 75 Years
• Gender Eligibility Details: Self-identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female between the ages of 25 to 75
• BMI between 30 and 45
• Not currently participating in any other weight management programs
• Self-reports wanting to lose weight
• Willing to follow recommendations in the study protocol and attend weekly group intervention for 12 weeks and a 3-month follow-up group (one in-person group per month and one phone call per month)
• Ability to attend 4 assessment appointments over the course of the study period (at baseline, 3-months, 6-months, 12-months).
• Willing to be randomized into any of the two study arms and willing to adhere to guidelines and recommendations associated with the study arm they are randomized into

You may not qualify if:

• Cannot commit to weekly group times. Participants must be available for at least one group time of each intervention arm in order to be eligible to participate.
• Participated in a weight loss intervention in the past six months
• Participants who are pregnant (or less than 6 months post partum) or planning to become pregnant in the next 12 months
• Weight loss of \> 5kg (\~11 lb) in the previous 6 months
• History of, or current, clinically diagnosed eating disorder or exhibiting clinical symptoms of an eating disorder but undiagnosed (EDE-Q ≥ 4.0 unless clinical judgement indicates otherwise)
• Reported health problems that make weight loss or unsupervised exercise unsafe or unreasonable (as measured by the PAR-Q+) where a doctor's note is not provided
• Resting systolic blood pressure \>160 mmHg or resting diastolic blood pressure \>100 mmHg
• If any of the following medical conditions are present: Insulin dependent diabetes; Previous surgical procedure for weight loss; Major surgery within the previous 6 months; A history of heart problems (e.g., angina, bypass surgery, myocardial infarction) within the previous 6 months; Implanted cardiac defibrillator or pacemaker; Currently (or within the past 5 years) being treated for cancer; Inflammatory Bowel Disease (i.e., chronic inflammatory gastrointestinal disease such as Crohn's Disease or Ulcerative Colitis); Chronic Pain (e.g., fibromyalgia) that would prevent the participant from engaging in physical activity
• The participant is currently experiencing elevated symptoms of depression
• The participant is planning to move within the study period
• The participant consumes more than 14 alcoholic drinks per week or more than 3 drinks per day

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia Okanagan

Kelowna, British Columbia, V1V2J8, Canada

Location

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

• Lesley Lutes, PhD

  University of British Columbia- Okanagan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: July 27, 2020
• Study Start: November 22, 2019
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: July 27, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)