Testing a Tailored Approach to Long-Term Weight Loss Success
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Utah
About this trial
The purpose of this study is to develop and test an adaptive, individually tailored intervention to prevent weight regain in people who have intentionally lost weight. The main questions it aims to answer are:
* Is an adaptive intervention with tailored re-engagement support feasible for individuals following intentional weight loss? * Does this intervention prevent weight regain after intentional weight loss?
Participants will:
* Complete a baseline assessment of body measurements * Complete surveys on dietary intake, mental health, and physical activity
Participants will also engage in a 26-week program, which involves:
* Receive regular educational texts/emails * Fill out weekly online survey check-ins * Weigh themselves at least weekly on a scale provided by the study * Some participants may receive health coaching during portions of the study. * Assessments will be repeated for all participants at the end of the intervention period.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
BMI of ≥ 27 prior to weight loss
Lost ≥ 7% of body mass in the past 6 months
Weight loss was intentional
No plans for weight loss surgery in the next 6 months
Disqualifiers
Pregnant or within 12 months postpartum, or planning pregnancy
Uncontrolled conditions that affect overall health (cardiovascular, metabolic, renal, pulmonary, psychiatric, thyroid, cancers)
Food insecure
Bariatric surgery or cancer treatment within the past 5 years
Trial design
Design model
Single group
Treatments tested in this trial
Adaptive weight regain prevention
BehavioralAdaptive intervention that will tailor participant re-engagement with professional support (e.g. health coaches) based on behavioral triggers and anthropometric monitoring (diet changes, weight increase, failure to weigh weekly).
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Adaptive InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility - Participant Retention
Number of participants who continue to participate for all 26 weeks of the study and complete all study activities
Time frame
From enrollment to the end of the 26-week monitoring period2
Feasibility - Participant Adherence
Number of participants who complete all study activities, including weekly weigh-ins, weekly surveys, and pre/post study visits.
Time frame
From enrollment to the end of the 26-week monitoring period3
Efficacy - Participant Weight
Time frame
From enrollment to the end of the 26-week monitoring period4
Efficacy - Participant Dietary Intake
Dietary and nutritional data collected via self-report using the ASA24 (Automated Self-Administered 24-Hour Dietary Assessment Tool). This includes calories, protein, fats, and other nutrition information based on participant self-report of meals.
Time frame
From enrollment to the end of the 26-week monitoring periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov