NCT04291482

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
285

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 30, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

February 4, 2020

Last Update Submit

September 28, 2021

Conditions

Overweight and Obesity

Keywords

DietPhysical activityBehaviour changeBehaviour maintenanceWeight lossWithin-person designDigital health

Outcome Measures

Primary Outcomes (1)

  • Weight

    Mean difference in weight loss between groups at 6 months, in kilograms

    Change from baseline to 6 months

Secondary Outcomes (21)

  • Weight

    baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)

  • Height

    baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)

  • BMI

    baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)

  • Body fat %

    baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)

  • Systolic and diastolic blood pressure

    baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3)

  • +16 more secondary outcomes

Other Outcomes (1)

  • Demographic variables

    baseline (Time 0)

Study Arms (2)

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.

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.

Behavioral: Choosing Health Control

Interventions

Choosing Health InterventionBEHAVIORAL

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.

Intervention arm
Choosing Health ControlBEHAVIORAL

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.

Control arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with overweight and obesity (18+);
  • Individuals with a BMI 25 and higher at the baseline assessment.

You may not qualify if:

  • 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);
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SWPS University

Wroclaw, Silesian Voivodeship, 03-815, Poland

Location

Related Publications (1)

  • Kwasnicka 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.

    PMID: 33234638DERIVED

Related Links

MeSH Terms

Conditions

OverweightObesityMotor ActivityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorBody Weight Changes

Study Officials

  • Felix Naughton, PhD

    University of East Anglia

    PRINCIPAL INVESTIGATOR

  • Aleksandra Luszczynska, Prof

    SWPS University of Social Sciences and Humanities

    PRINCIPAL INVESTIGATOR

  • Dominika Kwasnicka, PhD

    SWPS University of Social Sciences and Humanities

    PRINCIPAL INVESTIGATOR

  • Martin Hagger, Prof

    University of California

    PRINCIPAL INVESTIGATOR

  • Eleanor Quested, PhD

    Curtin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Investigator and Outcomes Assessor will be blinded to participants study arm allocation. It is impossible to blind study participants and intervention providers, it is behavioural trial.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2020

First Posted

March 2, 2020

Study Start

July 30, 2020

Primary Completion

April 30, 2022

Study Completion

December 31, 2022

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

We will share anonymised data using Open Science Framework.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be available on the OSF after the study is completed.
Access Criteria
Anonymised data will be publicly available to access through the OSF.

Locations

PL(1)