OverweightNCT03522727
Using Implementation Intentions to Self-incentivise Weight-loss
A study testing Single self-incentivising implementation intention, Multiple self-incentivising implementation intentions and Self-generated self-incentivising implementation intentions in people with Overweight, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
The aim of the present research is to test the effect of helping people to reward themselves when they have successfully lost weight and the impact this will have on subsequent weight. Each participant will be randomly allocated to one of four conditions. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Single self-incentivising implementation intention, Multiple self-incentivising implementation intentions and Self-generated self-incentivising implementation intentions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 4 May 2018to 31 Aug 2018
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18+
Who cannot join
- Unable or unwilling to complete questionnaire
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Online study
Manchester, M13 9PL
University of Manchester
Manchester, M13 9PL
About this study
The aim of the present research is to test the effect of helping people to reward themselves when they have successfully lost weight and the impact this will have on subsequent weight. Each participant will be randomly allocated to one of four conditions. The trial requires 200 participants to perform a fully powered statistical analysis. The four conditions are: (1) a control condition, (2) intervention 1 (form a single self-incentivising implementation intention from a drop-down menu), (3) intervention 2 (form multiple self-incentivising implementation intentions from a drop-down menu), or (4) intervention 3 (asked to form a single self-incentivising implementation intention of their own devising). The main outcome measure will be BMI, which will be self-reported.
- Conditions
- Overweight
- Being tested
- Single self-incentivising implementation intention, Multiple self-incentivising implementation intentions, Self-generated self-incentivising implementation intentions
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single self-incentivising implementation intentionBehavioural
Participants are asked to form a single self-incentivising implementation intention (if-then plans)
Multiple self-incentivising implementation intentionsBehavioural
Participants are asked to form multiple self-incentivising implementation intentions (if-then plans)
Self-generated self-incentivising implementation intentionsBehavioural
Participants are asked to form a self-incentivising implementation intention (if-then plans) without a drop-down menu
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants will be asked to complete a questionnaire. |
| Intervention 1 | Experimental | Single self-incentivising implementation intention
After completing a questionnaire, participants will be asked to form a self-incentivising implementation intention:
Research shows that rewarding yourself for success can help you to lose weight, but that people often forget to reward themselves. We want you to plan to reward yourself if you achieve your personal weight-loss goal, at the end of 4 weeks. To help you do this, we would like you to complete the following sentence by telling us how you will reward yourself.
Please complete the following sentence with a reward of your own choosing.
If I lose at least ___lbs/kg by the end of 4 weeks, then I will reward myself by…
Drop down menu
Learning a new skill... Receives: Behavioral: Single self-incentivising implementation intention |
| Intervention 2 | Experimental | Multiple self-incentivising implementation intentions
After completing a questionnaire, participants will be asked to form self-incentivising implementation intentions:
Research shows that rewarding yourself for success can help you to lose weight, but that people often forget to reward themselves. We want you to plan to reward yourself if you achieve your personal weight-loss goal, at the end of 4 weeks. To help you do this, we would like you to complete the following sentence by telling us how you will reward yourself. You can choose as many rewards as you like! Please complete the following sentence with a reward of your own choosing.
If I lose at least ___lbs/kg by the end of 4 weeks, then I will reward myself by… and/or…
Drop down menu
Learning a new skill... Receives: Behavioral: Multiple self-incentivising implementation intentions |
| Intervention 3 | Experimental | Self-generated self-incentivising implementation intentions
After completing a questionnaire, participants will be asked to form a self-incentivising implementation intention:
Research shows that rewarding yourself for success can help you to lose weight, but that people often forget to reward themselves. We want you to plan to reward yourself if you achieve your personal weight-loss goal, at the end of 4 weeks. To help you do this, we would like you to complete the following sentence by telling us how you will reward yourself.
Please complete the following sentence with a reward of your own choosing.
If I lose at least ___lbs/kg by the end of 4 weeks, then I will reward myself by… Receives: Behavioral: Self-generated self-incentivising implementation intentions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Self-reported
Measured: 4 weeks
Actual Use of Self-Rewards
Self-reported
Measured: 4 weeks
Secondary outcomes (1)
Capabilities, opportunities and motivations
Self-reported
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start4 May 2018
- Primary completion25 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Armitage, University of Manchester
- Investigators
- Christopher Armitage, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522727
- Sponsor's protocol ID
- Davids/Coulthard_1
- Status last verified
- Oct 2018
- First submitted
- 1 May 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Implementation Intentions to Self-incentivise Weight-loss
- ClinicalTrials.gov ID
- NCT03522727
- Acronym / sponsor ID
- Davids/Coulthard_1
- Conditions
- Overweight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 4 May 2018 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 11 May 2018 (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.
The aim of the present research is to test the effect of helping people to reward themselves when they have successfully lost weight and the impact this will have on subsequent weight. Each participant will be randomly allocated to one of four conditions. The trial requires 200 participants to perform a fully powered statistical analysis. The four conditions are: (1) a control condition, (2) intervention 1 (form a single self-incentivising implementation intention from a drop-down menu), (3) intervention 2 (form multiple self-incentivising implementation intentions from a drop-down menu), or (4) intervention 3 (asked to form a single self-incentivising implementation intention of their own devising). The main outcome measure will be BMI, which will be self-reported.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants will be asked to complete a questionnaire. |
| Intervention 1 | Experimental | Behavioral: Single self-incentivising implementation intentionSingle self-incentivising implementation intention After completing a questionnaire, participants will be asked to form a self-incentivising implementation intention: Research shows that rewarding yourself for success can help you to lose weight, but that people often forget to reward themselves. We want you to plan to reward yourself if you achieve your personal weight-loss goal, at the end of 4 weeks. To help you do this, we would like you to complete the following sentence by telling us how you will reward yourself. Please complete the following sentence with a reward of your own choosing. If I lose at least ___lbs/kg by the end of 4 weeks, then I will reward myself by… Drop down menu Learning a new skill... |
| Intervention 2 | Experimental | Behavioral: Multiple self-incentivising implementation intentionsMultiple self-incentivising implementation intentions After completing a questionnaire, participants will be asked to form self-incentivising implementation intentions: Research shows that rewarding yourself for success can help you to lose weight, but that people often forget to reward themselves. We want you to plan to reward yourself if you achieve your personal weight-loss goal, at the end of 4 weeks. To help you do this, we would like you to complete the following sentence by telling us how you will reward yourself. You can choose as many rewards as you like! Please complete the following sentence with a reward of your own choosing. If I lose at least ___lbs/kg by the end of 4 weeks, then I will reward myself by… and/or… Drop down menu Learning a new skill... |
| Intervention 3 | Experimental | Behavioral: Self-generated self-incentivising implementation intentionsSelf-generated self-incentivising implementation intentions After completing a questionnaire, participants will be asked to form a self-incentivising implementation intention: Research shows that rewarding yourself for success can help you to lose weight, but that people often forget to reward themselves. We want you to plan to reward yourself if you achieve your personal weight-loss goal, at the end of 4 weeks. To help you do this, we would like you to complete the following sentence by telling us how you will reward yourself. Please complete the following sentence with a reward of your own choosing. If I lose at least ___lbs/kg by the end of 4 weeks, then I will reward myself by… |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18+
Key exclusion criteria (1 listed)
- Unable or unwilling to complete questionnaire
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 |
|---|---|---|
| Single self-incentivising implementation intentionParticipants are asked to form a single self-incentivising implementation intention (if-then plans) | Behavioural | Intervention 1 |
| Multiple self-incentivising implementation intentionsParticipants are asked to form multiple self-incentivising implementation intentions (if-then plans) | Behavioural | Intervention 2 |
| Self-generated self-incentivising implementation intentionsParticipants are asked to form a self-incentivising implementation intention (if-then plans) without a drop-down menu | Behavioural | Intervention 3 |
Primary outcome
Body Mass Index
Time frame: 4 weeks
Self-reported
Actual Use of Self-Rewards
Time frame: 4 weeks
Self-reported
1 secondary outcome
Capabilities, opportunities and motivations
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
Related trials for Overweight
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
Not yet recruitingPhase 3
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Not yet recruitingPhase 1/2
Investigating the Effects of 24 Hour LEAP2 Infusion in Individuals With Overweight and Obesity
Obesity & Overweight
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.
Christopher Armitage, PhD principal investigator
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single self-incentivising implementation intention, Multiple self-incentivising implementation intentions and Self-generated self-incentivising implementation intentions in people with Overweight, run by University of Manchester at 2 sites in United Kingdom.
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: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2018.