Self-Weighing: an Ecological Momentary Assessment (SWEMA)

October 3, 2018 updated by: Carly R Pacanowski, University of Delaware

Self-weighing's Psychological Effects: a Randomized Controlled Trial Using Ecological Momentary Assessment

The primary objective of this study is to experimentally test the momentary and more distal psychological effects of daily self weighing as compared to an active control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19711
        • University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: daily self-weighing
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.
Behavioral: daily temperature-taking
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
psychological response to daily self-weighing
Time Frame: 3 Months
  1. Daily self-weighing will result in significantly greater reactivity than daily-temperature-taking
  2. There will be no significance in mood ratings between daily self-weighing and daily temperature-taking groups for EMA recordings later in the day.
  3. The daily self-weighing group will report significantly more weight control behaviors at the end of the day as compared to the daily temperature-taking group.
3 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Identify moderators of response to daily self-weighing in a college-aged female population
Time Frame: 3 Months
  1. Participants with lower baseline dietary restraint scores will experience significantly greater success in preventing weight gain over 3 months in response to daily self-weighing as compared to daily temperature-taking, in comparison to those with higher baseline dietary restraint scores
  2. Participants with higher baseline body satisfaction, lower body consciousness, and higher-self esteem will have significantly more favorable reactions to daily self-weighing, both in terms of momentary mood and prevention of weight gain over 3 months
  3. Baseline weight status will moderate the effectiveness of daily self-weighing as a weight gain prevention tool, such that it will work significantly better for overweight patients.
3 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17A00813

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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Conditions

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