Overweight and ObesityNCT04291482
A Theory-based Digital Intervention to Promote Weight Loss and Weight Loss Maintenance
A study testing Choosing Health Intervention in people with Overweight and Obesity, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
Trial summary
Obesity can severely reduce quality and longevity of life and there is an urgent need to help people lose weight and maintain weight loss long term. Digital behaviour change interventions targeting diet and physical activity have the potential for public health gain; however, these interventions are often not… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Choosing Health Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jul 2020to 31 Dec 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults with overweight and obesity (18+);
- Individuals with a BMI 25 and higher at the baseline assessment.
Who cannot join
- Individuals who self-report a physical condition or impairment preventing them from being physically active or losing excess body weight;
- Individuals who have had a bariatric surgery or are planning to have one within the next 12 months;
- Individuals who are currently participating in another weight loss program (e.g., regular meetings with personal trainer);
- Individuals who report any contradictions to exercise as indicated by the PAR-Q or pregnant women who consulted their doctor to obtain approval to take part in the study and did not get the approval;
- Individuals who do not have a mobile phone with access to the internet;
- Individuals who are currently participating in another weight loss program (e.g., regular meetings with personal trainer);
Show all 10Show fewer
- Pregnant women;
- Individuals who are planning to move outside of the study region and are not willing to travel for study measurement sessions;
- Individuals who are on medication that causes weight gain;
- Individuals with a pacemaker (the scale used in the study is not appropriate for use in these individuals).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Theory-based Digital Intervention to Promote Weight Loss and Weight Loss Maintenance (Choosing Health): A Randomised Controlled Trial With Within Person Assessment
Obesity can severely reduce quality and longevity of life and there is an urgent need to help people lose weight and maintain weight loss long term. Digital behaviour change interventions targeting diet and physical activity have the potential for public health gain; however, these interventions are often not adequately tailored to the participants. The aim of this study is to develop and test a digital intervention to help people make sustainable changes to diet and physical activity, and consequently their weight. This study is a hybrid trial that will evaluate the effectiveness, cost-effectiveness and implementation of the Choosing Health program among overweight/obese adults.
This study is a two-group randomised controlled trial (RCT) with within person assessment. Participants (N=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, Ecological Momentary Assessment (EMA) will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content. Control group will receive non-tailored factual weight loss advice. Primary outcome is mean difference in weight loss between groups at 6 months, in kilograms. Key outcomes will be measured at baseline, 3-, 6- and 12 months. Data will be analysed using multilevel modelling and time series analysis.
This is the first weight loss intervention applying individualised digital tailoring based on continuous assessment of individual's psychological determinants of behaviour measured over time. The Choosing Health will offer insight into factors associated with success in making sustained changes to weight, and secondary outcomes, such as diet and physical activity.
Read the detailed description
Behavioural science offers theory-driven and evidence-based behaviour change techniques that can support people in losing weight and maintaining it long term. These techniques have not yet been assessed in within-person studies that not only examine aggregated between-group effects (e.g., intervention versus control comparisons) but also determine personal trajectories of weight loss and maintenance and tailor accordingly to the strongest predictors of outcomes. The aim of the proposed study is to develop and test a digital intervention that uses Ecological Momentary Assessment (EMA) and tailors the evidence-based behaviour change techniques that are based on theory to the strongest predictors of outcomes (based on EMA responses collected over time).
This study will determine the effectiveness and cost-effectiveness of the proposed intervention through the Randomised Controlled Trial (EMA tailored intervention versus control), with within person component embedded in the trial. Study hypothesis is that participants in the EMA tailored intervention group will lose significantly more weight than participants in the control group from baseline to 6 months (post program comparison - primary outcome) and at 12 months (maintenance effects assessment - secondary outcome).
This is a two-group intervention trial adopting a randomised controlled design. It is a hybrid trial assessing intervention effectiveness, cost-effectiveness and implementation. This study has within person component embedded in the design and intervention group will answer EMA questions during the initial 3 months of the study and will receive tailored intervention at month 3 combined with additional EMA. There are two phases of the 6-month intervention (I) observational EMA phase and (II) active intervention phase.
The proposed intervention is delivered online through emails and text messages and based on the EMA responses in phase I, it is tailored in phase II. The intervention will have a non-automatic component, meaning trained facilitators will answer participants' queries and provide additional resources if and when needed to improve the engagement with the intervention. The study meets CONSORT criteria for RCTs and study ethical approval was obtained from SWPS University of Social Sciences and Humanities, Wroclaw, Poland (approval number 03/P/12/2019).
- Conditions
- Overweight and Obesity
- Being tested
- Choosing Health Intervention, Choosing Health Control
- Keywords
- Diet, Physical activity, Behaviour change, Behaviour maintenance, Weight loss, Within-person design, Digital health
- Medical subject headings
- Overweight, Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choosing Health InterventionBehavioural
The intervention consists of information materials provided at baseline in a form of eBook or a physical book depending on participants preferences. The book includes the rationale for the intervention, basic information on healthy eating and behaviour change and tables allowing self-monitoring of weight, physical activity and eating (i.e., brief food diary). The book is non-tailored and it has weekly tasks for the participants to complete during 26 weeks (initial 6 months) to support their weight loss. The intervention group will also receive a series of daily text messages and weekly email messages supporting their weight loss and promoting weight loss maintenance. In phase I (month 0-3), the messages and emails will be generic and factual; in the phase II of the intervention, participants will receive text messages and emails tailored to the strongest predictors of outcomes identified in phase I.
Choosing Health ControlBehavioural
The control consists of information materials provided at baseline in a form of eBook or a physical book depending on participants preferences. The book includes the rationale for the intervention and basic information on healthy eating and physical activity. The control group will also receive monthly email messages with generic and factual information.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | The intervention group participants will be assessed with EMA and they will provide daily data regarding their predictors of weight loss outcomes and their adherence to the personal weight loss plan (phase I, month 0-3). Then participants will receive tailored information regarding the most predictive factors relevant to their weight loss trajectories (phase II, month 3-6). The information will be tailored and delivered through emails and text messages. Receives: Behavioral: Choosing Health Intervention |
| Control arm | Other | Control group participants will receive basic educational weight loss information in a form of educational factual emails and text messages. Receives: Behavioral: Choosing Health Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Mean difference in weight loss between groups at 6 months, in kilograms
Measured: Change from baseline to 6 months
Secondary outcomes (21)
Weight
Objective measures of weight in kilograms
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Height
Objective measures of height in centimetres
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
BMI
Weight and height will be combined to report BMI in kg/m^2
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Body fat %
Objective measures of body fat %
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Systolic and diastolic blood pressure
Objective measures of systolic and diastolic blood pressure measured in units of millimeters of mercury (mmHg)
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Diet
Measured with the Dietary Instrument for Nutrition Education (fatty foods, fruit and vegetable, and sugary food consumption). High scores are indicative of high consumption. Higher scores for fruit and vegetable mean a better outcome (0-3 scale; 1 item) and higher scores for fatty foods (0-24; 8 items on 0-3 scale) and sugary food (0-9; 3 items on 0-3 scale) mean a worse outcome. The minimum values are 0 and the maximum values are specified above in brackets.
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Alcohol
Measured with the Audit C; scale 0-12, high scores are indicative of high consumption.
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Physical activity (self-reported) and sitting time
Measured with the International Physical Activity Questionnaire short version, the minimum value is 0 (no activity), higher scores mean a better outcome. All activity will be converted to minutes before calculating MET minutes (total score). In each category a maximum of 21 hours of activity are permitted a week (3 hours X 7 days). To calculate MET minutes a week the MET value given (walking = 3.3, moderate activity = 4, vigorous activity = 8) will be multiplied by the minutes the activity was carried out and again by the number of days that that activity was undertaken. To get total MET minutes of physical activity a week the MET minutes achieved in each category (walking, moderate activity and vigorous activity) will be added.
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Sleep duration and quality
Measured with the Pittsburgh Sleep Quality Index. In scoring the Pittsburgh Sleep Quality Index, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Health related quality of life
Measured with the EQ-5D-5 L (this is the unabbreviated scale title), the scale has five domains each scored on 1-5 scale; min 5 maximum 25 for all domains combined) higher scores mean a worse outcome and visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine".
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Number of adverse effects
report of any adverse effects that may occur during the intervention
Measured: Through study completion, an average of 1 year
Self-reported measures of intentions
Theory-derived psychological construct measured with 2 items addressing intentions (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (higher intentions).
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of motivation
Theory-derived psychological construct measured with 2 items addressing motivation (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (higher motivation).
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of self-efficacy
Theory-derived psychological construct measured with 2 items addressing self-efficacy (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (higher self-efficacy).
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of attitudes
Theory-derived psychological construct measured with 2 items addressing attitudes (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (higher attitudes).
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of action planning
Theory-derived psychological construct measured with 8 items addressing action planning (1-5 scale), the minimum and maximum values for the scale are 8-40, and higher scores mean a better outcome (better action planning).
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of coping planning
Theory-derived psychological construct measured with 6 items addressing action planning (1-5 scale), the minimum and maximum values for the scale are 6-30, and higher scores mean a better outcome (better coping planning).
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of goal facilitation
Theory-derived psychological construct measured with 2 items addressing goal facilitation (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (better goal facilitation)
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of goal conflict
Theory-derived psychological construct measured with 2 items addressing goal conflict (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a worse outcome (higher goal conflict)
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of habit strength for physical activity
Theory-derived psychological construct measured with h self-report behavioural automaticity index for physical activity, 4 items (1-5 scale); the minimum and maximum values for the scale are 4-20, and higher scores mean a better outcome (habit strength)
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of habit strength for healthy eating
Theory-derived psychological construct measured with self-report behavioural automaticity index for healthy eating, 4 items (1-5 scale); the minimum and maximum values for the scale are 4-20, and higher scores mean a better outcome (habit strength)
Measured: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start30 Jul 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies 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
- Model description
- This is a two-group intervention trial adopting a randomised controlled design. It is a hybrid trial assessing intervention effectiveness, cost-effectiveness and implementation with embedded within person assessment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felix Naughton, PhD, Principal investigator, University of East AngliaAleksandra Luszczynska, Prof, Principal investigator, SWPS University of Social Sciences and HumanitiesDominika Kwasnicka, PhD, Principal investigator, SWPS University of Social Sciences and HumanitiesMartin Hagger, Prof, Principal investigator, University of CaliforniaEleanor Quested, PhD, Principal investigator, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291482
- Sponsor's protocol ID
- POIR.04.04.00-00-5CF3/18-00
- Status last verified
- Sep 2021
- First submitted
- 4 Feb 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share anonymised data using Open Science Framework.
Publications
Kwasnicka D, Palacz-Poborczyk I, Verboon P, Luszczynska A, Quested E, Robinson S, Gao L, Januszewicz A, Hagger MS, Pagoto S, Idziak P, Naughton F. A randomized controlled trial testing a digital intervention to promote weight loss and weight loss maintenance. Health Psychol. 2026 Apr 16. doi: 10.1037/hea0001607. Online ahead of print.
PubMed 41989407Kwasnicka D, Luszczynska A, Hagger MS, Quested E, Pagoto SL, Verboon P, Robinson S, Januszewicz A, Idziak P, Palacz I, Naughton F. Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial. BMJ Open. 2020 Nov 23;10(11):e040183. doi: 10.1136/bmjopen-2020-040183.
PubMed 33234638
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Theory-based Digital Intervention to Promote Weight Loss and Weight Loss Maintenance (Choosing Health): A Randomised Controlled Trial With Within Person Assessment
- ClinicalTrials.gov ID
- NCT04291482
- Acronym / sponsor ID
- POIR.04.04.00-00-5CF3/18-00
- Conditions
- Overweight and Obesity
- Keywords
- Diet, Physical activity, Behaviour change, Behaviour maintenance, Weight loss, Within-person design, Digital health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Mar 2020 (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.
Obesity can severely reduce quality and longevity of life and there is an urgent need to help people lose weight and maintain weight loss long term. Digital behaviour change interventions targeting diet and physical activity have the potential for public health gain; however, these interventions are often not adequately tailored to the participants. The aim of this study is to develop and test a digital intervention to help people make sustainable changes to diet and physical activity, and consequently their weight. This study is a hybrid trial that will evaluate the effectiveness, cost-effectiveness and implementation of the Choosing Health program among overweight/obese adults.
This study is a two-group randomised controlled trial (RCT) with within person assessment. Participants (N=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, Ecological Momentary Assessment (EMA) will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content. Control group will receive non-tailored factual weight loss advice. Primary outcome is mean difference in weight loss between groups at 6 months, in kilograms. Key outcomes will be measured at baseline, 3-, 6- and 12 months. Data will be analysed using multilevel modelling and time series analysis.
This is the first weight loss intervention applying individualised digital tailoring based on continuous assessment of individual's psychological determinants of behaviour measured over time. The Choosing Health will offer insight into factors associated with success in making sustained changes to weight, and secondary outcomes, such as diet and physical activity.
Detailed description
Behavioural science offers theory-driven and evidence-based behaviour change techniques that can support people in losing weight and maintaining it long term. These techniques have not yet been assessed in within-person studies that not only examine aggregated between-group effects (e.g., intervention versus control comparisons) but also determine personal trajectories of weight loss and maintenance and tailor accordingly to the strongest predictors of outcomes. The aim of the proposed study is to develop and test a digital intervention that uses Ecological Momentary Assessment (EMA) and tailors the evidence-based behaviour change techniques that are based on theory to the strongest predictors of outcomes (based on EMA responses collected over time).
This study will determine the effectiveness and cost-effectiveness of the proposed intervention through the Randomised Controlled Trial (EMA tailored intervention versus control), with within person component embedded in the trial. Study hypothesis is that participants in the EMA tailored intervention group will lose significantly more weight than participants in the control group from baseline to 6 months (post program comparison - primary outcome) and at 12 months (maintenance effects assessment - secondary outcome).
This is a two-group intervention trial adopting a randomised controlled design. It is a hybrid trial assessing intervention effectiveness, cost-effectiveness and implementation. This study has within person component embedded in the design and intervention group will answer EMA questions during the initial 3 months of the study and will receive tailored intervention at month 3 combined with additional EMA. There are two phases of the 6-month intervention (I) observational EMA phase and (II) active intervention phase.
The proposed intervention is delivered online through emails and text messages and based on the EMA responses in phase I, it is tailored in phase II. The intervention will have a non-automatic component, meaning trained facilitators will answer participants' queries and provide additional resources if and when needed to improve the engagement with the intervention. The study meets CONSORT criteria for RCTs and study ethical approval was obtained from SWPS University of Social Sciences and Humanities, Wroclaw, Poland (approval number 03/P/12/2019).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-group intervention trial adopting a randomised controlled design. It is a hybrid trial assessing intervention effectiveness, cost-effectiveness and implementation with embedded within person assessment.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Choosing Health InterventionThe intervention group participants will be assessed with EMA and they will provide daily data regarding their predictors of weight loss outcomes and their adherence to the personal weight loss plan (phase I, month 0-3). Then participants will receive tailored information regarding the most predictive factors relevant to their weight loss trajectories (phase II, month 3-6). The information will be tailored and delivered through emails and text messages. |
| Control arm | Other | Behavioral: Choosing Health ControlControl group participants will receive basic educational weight loss information in a form of educational factual emails and text messages. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with overweight and obesity (18+);
- Individuals with a BMI 25 and higher at the baseline assessment.
Key exclusion criteria (10 listed)
- Individuals who self-report a physical condition or impairment preventing them from being physically active or losing excess body weight;
- Individuals who have had a bariatric surgery or are planning to have one within the next 12 months;
- Individuals who are currently participating in another weight loss program (e.g., regular meetings with personal trainer);
- Individuals who report any contradictions to exercise as indicated by the PAR-Q or pregnant women who consulted their doctor to obtain approval to take part in the study and did not get the approval;
- Individuals who do not have a mobile phone with access to the internet;
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 |
|---|---|---|
| Choosing Health InterventionThe intervention consists of information materials provided at baseline in a form of eBook or a physical book depending on participants preferences. The book includes the rationale for the intervention, basic information on healthy eating and behaviour change and tables allowing self-monitoring of weight, physical activity and eating (i.e., brief food diary). The book is non-tailored and it has weekly tasks for the participants to complete during 26 weeks (initial 6 months) to support their weight loss. The intervention group will also receive a series of daily text messages and weekly email messages supporting their weight loss and promoting weight loss maintenance. In phase I (month 0-3), the messages and emails will be generic and factual; in the phase II of the intervention, participants will receive text messages and emails tailored to the strongest predictors of outcomes identified in phase I. | Behavioural | Intervention arm |
| Choosing Health ControlThe control consists of information materials provided at baseline in a form of eBook or a physical book depending on participants preferences. The book includes the rationale for the intervention and basic information on healthy eating and physical activity. The control group will also receive monthly email messages with generic and factual information. | Behavioural | Control arm |
Primary outcome
Weight
Time frame: Change from baseline to 6 months
Mean difference in weight loss between groups at 6 months, in kilograms
21 secondary outcomes
Weight
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Height
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
BMI
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Body fat %
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Systolic and diastolic blood pressure
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Diet
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Alcohol
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Physical activity (self-reported) and sitting time
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Sleep duration and quality
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Health related quality of life
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Number of adverse effects
Time frame: Through study completion, an average of 1 year
Self-reported measures of intentions
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of motivation
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of self-efficacy
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of attitudes
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of action planning
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of coping planning
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of goal facilitation
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of goal conflict
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of habit strength for physical activity
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Self-reported measures of habit strength for healthy eating
Time frame: baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 41989407Kwasnicka D, Palacz-Poborczyk I, Verboon P, Luszczynska A, Quested E, Robinson S, Gao L, Januszewicz A, Hagger MS, Pagoto S, Idziak P, Naughton F. A randomized controlled trial testing a digital intervention to promote weight loss and weight loss maintenance. Health Psychol. 2026 Apr 16. doi: 10.1037/hea0001607. Online ahead of print.
- Derived from this study: PubMed 33234638Kwasnicka D, Luszczynska A, Hagger MS, Quested E, Pagoto SL, Verboon P, Robinson S, Januszewicz A, Idziak P, Palacz I, Naughton F. Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial. BMJ Open. 2020 Nov 23;10(11):e040183. doi: 10.1136/bmjopen-2020-040183.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share anonymised data using Open Science Framework.
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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.
Felix Naughton, PhD principal investigator
University of East Anglia
Aleksandra Luszczynska, Prof principal investigator
SWPS University of Social Sciences and Humanities
Dominika Kwasnicka, PhD principal investigator
SWPS University of Social Sciences and Humanities
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choosing Health Intervention in people with Overweight and Obesity, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
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 2 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Results are not available in the source record.
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?
Weight (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04291482, which also lists 2 linked publications.
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 29 Sep 2021.