- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03273491
Self-Weighing: an Ecological Momentary Assessment (SWEMA)
Self-weighing's Psychological Effects: a Randomized Controlled Trial Using Ecological Momentary Assessment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Two significant public health problems, obesity and eating disorders, are prevalent during emerging adulthood, a unique stage of life between ages 18 and 25. Over half of emerging adults experience weight gain and/or disordered eating (e.g. overly restrictive dieting, binge eating); both of which contribute to obesity. Because many emerging adults attend college, the college community represents a viable population for implementing interventions to prevent weight gain, while not triggering disordered eating.
A promising strategy for preventing weight gain during college is daily self-weighing, an example of behavioral self-monitoring, an evidence-based strategy for weight control. Self-monitoring is fundamental to behavior change: feedback allows the user to evaluate progress in relation to a goal and modify behavior. Despite self-monitoring being recommended, some evidence suggests that self-monitoring strategies, self-weighing in particular, may have unintended psychological consequences; the concern being that negative mood states could precipitate disordered eating. Alternatively, other evidence suggests positive psychological outcomes related to daily self-weighing in young adults.
Technological advances have allowed for users to track personal health information in real time. Given that 60% of U.S. adults track weight, diet, or exercise, and 92% of adults aged 18-34 own a smartphone, electronic self-monitoring is feasible in this population. What is less known is individuals' psychological and behavioral response to self-monitoring. This original, important study will contribute to the fields of obesity and eating disorders and experimentally test the psychological effects of this daily weight-control intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19711
- University of Delaware
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- Between the ages of 18 and 26
- UD student
- Owns a smart phone
- If participant does not currently have an eating disorder or has never had one in the past
Exclusion Criteria:
- If participant currently has an eating disorder or has had one in the past
- If participant answers "yes" to 3 or more items in SCOFF
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Daily Self-Weighing Group
Participants will be provided with a scale and instructions necessary to engage in daily self-weighing, first thing in the morning for the next three months. Height and weight will be measured using standard procedures Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body. Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT. |
Participants are provided with a wifi-enabled scale and asked to weigh themselves daily, first thing in the morning.
|
Active Comparator: Daily Temperature-Taking Group
Participants will be provided with a thermometer and instructions necessary to engage in daily temperature-taking, first thing in the morning for the next three months. Height and weight will be measured using standard procedures Questionnaires will be administered at baseline and EOT: Sociodemographic questions (i.e. age, race/ethnicity, self-weighing frequency, weight goals will be collected at baseline. To assess factors that may modify reaction to intervention condition,a questionnaire will assess participant's eating attitudes, behaviors, and perception of their body. Questionnaires (baseline, end of Week 1, 2, 3, 4 and EOT): In order to compare results with published studies assessing constructs over varying time frames, self-esteem, anxiety, and depression will be measured at baseline, weekly for the first month, and again at EOT. |
Participants are provided with a wifi-enabled thermometer and asked to take their temperature daily, first thing in the morning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychological response to daily self-weighing
Time Frame: 3 Months
|
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identify moderators of response to daily self-weighing in a college-aged female population
Time Frame: 3 Months
|
|
3 Months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17A00813
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Daily Self-weighing
-
Fundacio Salut i Envelliment UABFondo de Investigacion Sanitaria; Sociedad Española de Geriatría y GerontologíaCompletedQuality of Life | Activities of Daily Living | Accidental Falls | Self-EfficacySpain
-
University of Texas Southwestern Medical CenterCompleted
-
University of PatrasCompleted
-
GE HealthcareLaboratory Corporation of AmericaCompletedStudy to Determine Dosage of OPTISON in Children Between ≥9 and <18 Years of Age Weighing ≥20 kgUnited States
-
Masimo CorporationTerminatedRespiration RateUnited States
-
University of Applied Sciences for Health Professions...LICA Life Care GmbHNot yet recruitingActivities of Daily Living
-
Parker Research InstituteUniversity of Southern Denmark; University College of Northern Denmark; Municipality...Completed
-
Chinese University of Hong KongNot yet recruitingPhysical Competence | Daily Behaviour
-
Boston Children's HospitalCompletedNew Daily Persistent Headache (NDPH)United States
-
Clalit Health ServicesTel Aviv UniversityCompletedLimited Participation in Daily Life ActivitiesIsrael
Clinical Trials on daily self-weighing
-
Cornell UniversityCompleted
-
University of North Carolina, Chapel HillCompleted
-
University of Alabama at BirminghamIndiana University; Cornell UniversityActive, not recruitingOverweight and ObesityUnited States
-
University of GeorgiaCompleted
-
Cornell UniversityCompleted
-
The Miriam HospitalCompleted
-
The University of Tennessee, KnoxvilleCompleted
-
Milton S. Hershey Medical CenterRecruitingAnorexia Nervosa | Eating DisordersUnited States
-
Kaiser PermanenteCompleted