Pregnancy Weight GainNCT06129461
A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings in Pregnancy
A study of Pregnancy Weight Gain and Eating Disorders, run by University at Albany.
Trial summary
Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to adverse health outcomes in gestation, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater risk of deviation from recommended gestational weight gain trajectories, especially in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Weight Gain, Eating Disorders, Perinatal Problems
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2023to 14 Nov 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- Current residence in the United States
- Fluency in English
- Currently pregnant in the second trimester
- Experience of any food cravings
Who cannot join
- None beyond not meeting inclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings as Predictors of Disordered Eating in Pregnant People
Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to adverse health outcomes in gestation, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater risk of deviation from recommended gestational weight gain trajectories, especially in those engaged in binge and loss of control eating. This study will explore the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings as powerful and modifiable predictors of binge and LOC eating in pregnancy.
Read the detailed description
Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to a range of adverse health outcomes in pregnancy, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater rates of deviation from recommended weight gain trajectories, especially in those engaged in binge and loss of control eating. Food cravings are powerful triggers of binge and loss of control eating in non-pregnant populations with preliminary evidence linking cravings to disordered eating behaviors and greater weight gain in pregnancy as well. This study builds on preliminary evidence to suggest that acceptance-based approaches are effective in reducing the adverse impacts of cravings on behavior by exploring the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants as predictors of maladaptive eating behaviors and deviations from recommended gestational weight gain trajectories.
The efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants will be examined in a randomized controlled trial. Pregnant individuals in the second trimester (n = 130) who endorse current cravings will be randomly assigned to the intervention or an untreated control group. The intervention group will participate in a single-session, self-guided online workshop imparting skills grounded in Acceptance and Commitment Therapy, including acceptance, defusion, and present-moment awareness. Both groups will complete comprehensive assessments at baseline, one-month follow-up, and at full-term. The results of this initial efficacy trial will inform the integration of acceptance-based self-guided health coaching targeting food cravings into routine prenatal care to prevent adverse outcomes associated with disordered eating behaviors in pregnancy.
- Being tested
- Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy
- Keywords
- gestational weight gain, loss of control eating, binge eating, food craving, mobile health intervention, single session intervention, Acceptance and Commitment Therapy
- Medical subject headings
- Gestational Weight Gain, Feeding and Eating Disorders, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancyBehavioural
Participants in the intervention will learn acceptance-based strategies for reducing the adverse impact of food cravings on eating behaviors. Unlike control-based strategies, acceptance-based strategies do not attempt to change the content or frequency of thoughts; rather, they foster willingness to acknowledge and experience uncontrollable thoughts, urges, and emotions as what they are - nothing more, nothing less. Acceptance-based approaches have demonstrated efficacy in reducing the adverse impact of food cravings on eating behaviors in non-pregnant samples.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The intervention group will participate in a single-session, self-guided online intervention imparting skills grounded in Acceptance and Commitment Therapy. The one-hour workshop guides participants through evidence-based exercises, brief video clips, and reflection activities designed to clarify values and teach skills to foster acceptance, defusion, and present-moment awareness. Receives: Behavioral: Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancy |
| Control | No intervention | Participants in the control group will not receive any intervention; they will complete assessments on the same schedule as the intervention group (baseline, 1 month, at full term) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Eating Behaviors Screening Tool
Eating disorder symptoms, including frequency of binge and loss-of-control eating
Measured: From study entry in 2nd trimester of pregnancy through delivery
Gestational weight gain
Deviations from recommended gestational weight gain trajectories (in U.S. lbs)
Measured: From study entry in 2nd trimester of pregnancy through delivery
Food Craving Questionnaire - Trait - Reduced
Frequency and intensity of food craving experiences
Measured: From study entry in 2nd trimester of pregnancy through delivery
Secondary outcomes (4)
Food Craving Acceptance and Action Questionnaire
Acceptance of and willingness to experience food cravings
Measured: Assessed at baseline and 1-month post-intervention
Obsessive Compulsive Eating Scale
Intrusive thoughts and urges related to a craved target
Measured: Assessed at baseline and 1-month post-intervention
White Bear Suppression Inventory
Thought suppression
Measured: Assessed at baseline and 1-month post-intervention
Detail and Flexibility Questionnaire
Cognitive flexibility
Measured: Assessed at baseline and 1-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start15 Nov 2023 (estimated)
- Primary completion14 Nov 2024 (estimated)
- Study completion14 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pregnancy Weight GainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University at Albany
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Julia Hormes, University at Albany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129461
- Sponsor's protocol ID
- 23E225
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified and aggregate data may be made available to other researchers upon reasonable request.
Publications
Costello K, Timko CA, Anderson D, Hormes JM. Validation of the intolerance of uncertainty scale-12 in a sample of pregnant people. BMC Pregnancy Childbirth. 2025 Mar 27;25(1):363. doi: 10.1186/s12884-025-07434-1.
PubMed 40148844Hormes JM, Timko CA. A clinical trial protocol of a single-session self-guided acceptance-based online intervention targeting food cravings as predictors of disordered eating in pregnant people. Contemp Clin Trials. 2024 May;140:107515. doi: 10.1016/j.cct.2024.107515. Epub 2024 Mar 26.
PubMed 38537903
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings as Predictors of Disordered Eating in Pregnant People
- ClinicalTrials.gov ID
- NCT06129461
- Acronym / sponsor ID
- 23E225
- Keywords
- gestational weight gain, loss of control eating, binge eating, food craving, mobile health intervention, single session intervention, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University at AlbanyUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 15 Nov 2023 (estimated)
- Primary completion
- 14 Nov 2024 (estimated)
- Study completion
- 14 Nov 2024 (estimated)
- First posted
- 13 Nov 2023 (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.
Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to adverse health outcomes in gestation, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater risk of deviation from recommended gestational weight gain trajectories, especially in those engaged in binge and loss of control eating. This study will explore the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings as powerful and modifiable predictors of binge and LOC eating in pregnancy.
Detailed description
Pregnancy is a time of heightened risk for disordered eating behaviors, which have been linked to a range of adverse health outcomes in pregnancy, delivery, and the postpartum. These adverse outcomes may at least in part be mediated by greater rates of deviation from recommended weight gain trajectories, especially in those engaged in binge and loss of control eating. Food cravings are powerful triggers of binge and loss of control eating in non-pregnant populations with preliminary evidence linking cravings to disordered eating behaviors and greater weight gain in pregnancy as well. This study builds on preliminary evidence to suggest that acceptance-based approaches are effective in reducing the adverse impacts of cravings on behavior by exploring the efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants as predictors of maladaptive eating behaviors and deviations from recommended gestational weight gain trajectories.
The efficacy of a single-session, self-guided online acceptance-based intervention targeting food cravings in pregnant participants will be examined in a randomized controlled trial. Pregnant individuals in the second trimester (n = 130) who endorse current cravings will be randomly assigned to the intervention or an untreated control group. The intervention group will participate in a single-session, self-guided online workshop imparting skills grounded in Acceptance and Commitment Therapy, including acceptance, defusion, and present-moment awareness. Both groups will complete comprehensive assessments at baseline, one-month follow-up, and at full-term. The results of this initial efficacy trial will inform the integration of acceptance-based self-guided health coaching targeting food cravings into routine prenatal care to prevent adverse outcomes associated with disordered eating behaviors in pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancyThe intervention group will participate in a single-session, self-guided online intervention imparting skills grounded in Acceptance and Commitment Therapy. The one-hour workshop guides participants through evidence-based exercises, brief video clips, and reflection activities designed to clarify values and teach skills to foster acceptance, defusion, and present-moment awareness. |
| Control | No intervention | –Participants in the control group will not receive any intervention; they will complete assessments on the same schedule as the intervention group (baseline, 1 month, at full term) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and older
- Current residence in the United States
- Fluency in English
- Currently pregnant in the second trimester
- Experience of any food cravings
Key exclusion criteria (1 listed)
- None beyond not meeting inclusion criteria
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 |
|---|---|---|
| Single-session acceptance-based online workshop targeting food cravings as predictors of loss of control and binge eating in pregnancyParticipants in the intervention will learn acceptance-based strategies for reducing the adverse impact of food cravings on eating behaviors. Unlike control-based strategies, acceptance-based strategies do not attempt to change the content or frequency of thoughts; rather, they foster willingness to acknowledge and experience uncontrollable thoughts, urges, and emotions as what they are - nothing more, nothing less. Acceptance-based approaches have demonstrated efficacy in reducing the adverse impact of food cravings on eating behaviors in non-pregnant samples. | Behavioural | Treatment |
Primary outcome
Prenatal Eating Behaviors Screening Tool
Time frame: From study entry in 2nd trimester of pregnancy through delivery
Eating disorder symptoms, including frequency of binge and loss-of-control eating
Gestational weight gain
Time frame: From study entry in 2nd trimester of pregnancy through delivery
Deviations from recommended gestational weight gain trajectories (in U.S. lbs)
Food Craving Questionnaire - Trait - Reduced
Time frame: From study entry in 2nd trimester of pregnancy through delivery
Frequency and intensity of food craving experiences
4 secondary outcomes
Food Craving Acceptance and Action Questionnaire
Time frame: Assessed at baseline and 1-month post-intervention
Obsessive Compulsive Eating Scale
Time frame: Assessed at baseline and 1-month post-intervention
White Bear Suppression Inventory
Time frame: Assessed at baseline and 1-month post-intervention
Detail and Flexibility Questionnaire
Time frame: Assessed at baseline and 1-month post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 40148844Costello K, Timko CA, Anderson D, Hormes JM. Validation of the intolerance of uncertainty scale-12 in a sample of pregnant people. BMC Pregnancy Childbirth. 2025 Mar 27;25(1):363. doi: 10.1186/s12884-025-07434-1.
- Derived from this study: PubMed 38537903Hormes JM, Timko CA. A clinical trial protocol of a single-session self-guided acceptance-based online intervention targeting food cravings as predictors of disordered eating in pregnant people. Contemp Clin Trials. 2024 May;140:107515. doi: 10.1016/j.cct.2024.107515. Epub 2024 Mar 26.
- Individual participant dataSharing planned: Undecided. Deidentified and aggregate data may be made available to other researchers upon reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
A study of Pregnancy Weight Gain and Eating Disorders, run by University at Albany.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia M. Hormes, Ph.D. (518-442-4911, jhormes@albany.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prenatal Eating Behaviors Screening Tool (time frame: From study entry in 2nd trimester of pregnancy through delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06129461, which also lists 2 linked publications.
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 13 Nov 2023.