Daily Self-weighingSWEMANCT03273491
Self-Weighing: an Ecological Momentary Assessment
A study testing daily self-weighing and daily temperature-taking in people with Daily Self-weighing and Daily Temperature-taking, run by University of Delaware at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Daily Self-weighing, Daily Temperature-taking
- What is being tested?
- daily self-weighing and daily temperature-taking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 29 Dec 2017
- 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 to 26 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Daily Self-weighing, Daily Temperature-taking
- Being tested
- daily self-weighing, daily temperature-taking
- Keywords
- self-weighing, weight gain, Ecological Momentary Assessment, mood, emerging adulthood, obesity, eating disorders
- Medical subject headings
- Weight Gain, Obesity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daily self-weighingBehavioural
Participants are provided with a wifi-enabled scale and asked to weigh themselves daily, first thing in the morning.
daily temperature-takingBehavioural
Participants are provided with a wifi-enabled thermometer and asked to take their temperature daily, first thing in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Daily Self-Weighing Group | Experimental | 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. Receives: Behavioral: daily self-weighing |
| Daily Temperature-Taking Group | Active comparator | 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. Receives: Behavioral: daily temperature-taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychological response to daily self-weighing
- Daily self-weighing will result in significantly greater reactivity than daily-temperature-taking
- There will be no significance in mood ratings between daily self-weighing and daily temperature-taking groups for EMA recordings later in the day.
- 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.
Measured: 3 Months
Secondary outcomes (1)
Identify moderators of response to daily self-weighing in a college-aged female population
- 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
- 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
- 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.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start1 Jun 2017
- Primary completion20 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Daily Self-weighingStudies 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
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly R Pacanowski, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273491
- Sponsor's protocol ID
- 17A00813
- Acronym
- SWEMA
- Status last verified
- Oct 2018
- First submitted
- 1 Sep 2017
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-weighing's Psychological Effects: a Randomized Controlled Trial Using Ecological Momentary Assessment
- ClinicalTrials.gov ID
- NCT03273491
- Acronym / sponsor ID
- SWEMA / 17A00813
- Conditions
- Daily Self-weighing, Daily Temperature-taking
- Keywords
- self-weighing, weight gain, Ecological Momentary Assessment, mood, emerging adulthood, obesity, eating disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 6 Sep 2017 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily Self-Weighing Group | Experimental | Behavioral: daily self-weighingParticipants 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. |
| Daily Temperature-Taking Group | Active comparator | Behavioral: daily temperature-takingParticipants 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| daily self-weighingParticipants are provided with a wifi-enabled scale and asked to weigh themselves daily, first thing in the morning. | Behavioural | Daily Self-Weighing Group |
| daily temperature-takingParticipants are provided with a wifi-enabled thermometer and asked to take their temperature daily, first thing in the morning. | Behavioural | Daily Temperature-Taking Group |
Primary outcome
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.
1 secondary outcome
Identify moderators of response to daily self-weighing in a college-aged female population
Time frame: 3 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- Individual participant dataSharing planned: Yes
Related trials for Daily Self-weighing
Enrolling by invitation
Daily Goal Setting to Increase Everyday Physical Activity and Promote Cognitive Health in Midlife
Physical Inactivity, Walking
Recruiting
A Nurse-Led Weight Monitoring Intervention For Heart Failure Quality of LIfe and Self-Care
Heart Failure
Active, not recruiting
Adults Regulating Their Weight Everyday With Mobile Internet Support
Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing daily self-weighing and daily temperature-taking in people with Daily Self-weighing and Daily Temperature-taking, run by University of Delaware at 1 site in United States.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 4 Oct 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
psychological response to daily self-weighing (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2018.