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The Small Change Study to investigate the acceptability and feasibility of a small change approach to prevent weight gain

A randomised controlled trial to investigate the acceptability and feasibility of a small change approach to prevent weight gain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18309466
Enrollment
120
Registered
2022-04-12
Start date
2022-01-14
Completion date
Unknown
Last updated
2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight management Nutritional, Metabolic, Endocrine

Interventions

Participants are recruited through online and offline social networks, online and paper newsletters and newspapers, through public facilities (including community boards, advertisement boards, notice

Sponsors

Loughborough University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Body mass index 20 - 30 kg/m² 3. Access to an internet connection 4. Owns a smartphone 5. Has a UK mobile telephone number 6. Can speak and understand English

Exclusion criteria

Exclusion criteria: 1. Participating in another weight management trial or programme 2. Inability or unwillingness to provide online consent 3. Pregnant/a planned pregnancy in the next 6 months 4.Taking weight loss medications/other medication that impacts weight 5. Have a history of an eating disorder in the last 5 years/are currently experiencing an eating disorder

Design outcomes

Primary

MeasureTime frame
1. The acceptability and feasibility of an intervention that uses a small change approach to decrease calorie intake and/or increase energy expenditure to prevent weight gain, assessed using online questionnaires at weeks 2, 4, 6, 8, 10 and 12: 1.1. The acceptability of the small change intervention will be assessed using questions that will focus on assessing whether they adhered to the small change approach, whether participants liked using this approach and whether participants found it helpful to reduce their calorie intake behaviour. The questions will also assess whether the trial materials (educational video, text messages, small change diary and list of 20 suggested small dietary and physical activity changes) were helpful. 1.2. The feasibility of the small change intervention will be assessed using the number of participants randomised per month and the retention rates at follow-ups

Secondary

MeasureTime frame
As a feasibility trial, this study will not be powered to detect differences in weight, physical activity or food intake, but the researchers will conduct an exploratory analysis to assess the effect of a small change approach on weight, physical activity and food intake at follow up. 1. Weight: participants will be asked to send a photo of themselves standing on a set of scales (camera facing towards feet) that clearly displays their weight. Weight will be sought through pictures to make the measurement as objective as possible. Participants will be asked to weigh themselves in the morning, after going to the toilet and whilst wearing light or no clothing. Participants will be asked to weigh themselves using pounds or kilograms, but all weights will be converted to kilograms at the end of the study. Measured at baseline and 12-week follow-up 2. Physical activity measured using the Physical Activity Vital Signs questionnaire at baseline and 12-week follow-up 3. Food intake measured by participants reporting the frequency and quantity in which they consume 10 different foods at baseline and 12-week follow-up 4. Cognitive restraint of eating assessed using the revised version of the Three Factor Eating Questionnaire at baseline and 12-week follow-up 5. Self-efficacy for dietary behaviours related to weight management assessed using the Weight Efficacy Lifestyle Questionnaire (WEL-SF) at baseline and 12-week follow-up 6. Self-efficacy for physical activity behaviours related to weight management assessed using the Self-Efficacy for Exercise Scale at baseline and 12-week follow-up 7. Self-regulation of dietary and physical activity behaviours measured using the shortened version of the Self-Regulation Questionnaire (SRQ) at baseline and 12-week follow-up

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026