ObesityTAGGNCT02963428
Teaching Appropriate Gestational Weight Gain
A study testing Enhanced Care in people with Obesity, run by Geisinger Clinic at 1 site in United States.
Trial summary
The study aims to improve obstetrical care by managing gestational weight gain (GWG) among high risk women in an effort to reduce maternal and fetal complications. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Enhanced Care
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jul 2019
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pre-pregnancy body mass index of at least 30 kg/m2 (per patient report of weight)
- Less than 16 weeks gestation
- Gestational weight gain (GWG) less than < 11 pounds from their pre-pregnancy weight to time of potential study enrollment
- Singleton gestation
- Access to a phone
Who cannot join
- BMI less than 30 kg/m2
- Gestational age greater than or equal to 16 weeks
- Active diagnosis of cancer on their electronic health record problem list
- Acquired immunodeficiency syndrome (AIDS)
- Palliative medicine patients
- Multiple gestations
Show all 12Show fewer
- GWG in excess of 11 pounds prior to study enrollment
- Patients with Non-Geisinger prenatal care providers
- Vegan diet
- Malabsorptive conditions
- Previously enrolled in TAGG during prior pregnancy. Patient will be excluded from re-randomization
- Non-English Speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
The study aims to improve obstetrical care by managing gestational weight gain (GWG) among high risk women in an effort to reduce maternal and fetal complications.
Read the detailed description
The project is aimed at teaching women about the appropriate weight gain during pregnancy to optimize health outcomes for mothers and newborn babies. Obese gravida meeting inclusion criteria and none of the exclusion criteria will be offered enrollment in TAGG. Those that consent will be randomized to receive standard of care or enhanced care regarding gestational weight gain.
The primary outcome is the proportion of patients that gain less than 20 lbs over the course of the pregnancy. Secondary outcomes include patient knowledge and expectations, attitude about pregnancy weight gain, self-efficacy of ability to eat healthy, and eating, sleeping and physical activity behavior, perceived stress, psychological factors, patient-experience, involvement in care, and food security.
- Conditions
- Obesity
- Being tested
- Enhanced Care
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced CareBehavioural
Also called EC
In addition to standard of care, the study participants will also receive:
- An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | No intervention | Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider. |
| Enhanced Care (EC) | Experimental | In addition to standard of care, the study participants will also receive:
i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy. Receives: Behavioral: Enhanced Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational weight gain, adjusting for time in the study
Measured: at delivery
Secondary outcomes (13)
Patient knowledge and expectations factors
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient knowledge and expectations factors.
Measured: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Attitude on pregnancy weight gain
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient attitudes on pregnancy weight gain.
Measured: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Self-efficacy of healthy eating
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient self-efficacy of healthy eating.
Measured: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Eating, sleeping and physical activity behavior
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient eating, sleeping and physical activity behaviors.
Measured: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Patient-experience and involvement in care
Participants will be enrolled at baseline (Less than 16 6/7 weeks gestation) and be given a self-report survey tool developed using validated instruments to complete assessing these constructs. This survey tool will then be administered at 32-34 weeks gestation and 4-12 postpartum assessing end of pregnancy and post-intervention patient experience and involvement in their care.
Measured: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Delivery of large for gestational age infants
This measure will be obtained using electronic health record data and analyzed utilizing clinic data points as well as information gathered from patients through self-report survey data.
Measured: At Delivery
Diagnosis of gestational diabetes mellitus
This measure will be obtained using EHR data and analyzed utilizing clinic data points.
Measured: Baseline through 4-12 Weeks Postpartum
Neonatal intensive care unit (NICU) admissions
Measured: At Delivery
Cost of Treatment
Participant cost of treatment will be assessed utilizing claims data obtained from Geisinger Health Plan to compare the effectiveness of the intervention in reducing cost.
Measured: Baseline through 4-12 Weeks Postpartum
Mode of delivery
Clinical electronic health record data in regards to the participant mode of delivery will be utilized in statistical analyses to determine whether mode of delivery has an impact on other outcomes of interest.
Measured: At Delivery
Rate of gestational weight gain
Measured: Baseline through 4-12 weeks postpartum
Perceived stress measured via Perceived Stress Scale
Perceived Stress will be measured using the Perceived Stress Scale by Cohen et. al.
Measured: Baseline through 4-12 weeks postpartum
Psychological factors measured via Pregnancy Weight Gain Attitude Scale
Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et. al.
Measured: Baseline through 4-12 Weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University
- Responsible party
- Sponsor
- Investigators
- Awathif D Mackeen, MD, MPH, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963428
- Sponsor's protocol ID
- 2016-0205
- Acronym
- TAGG
- Status last verified
- Aug 2019
- First submitted
- 12 Oct 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Appropriate Gestational Weight Gain
- ClinicalTrials.gov ID
- NCT02963428
- Acronym / sponsor ID
- TAGG / 2016-0205
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Penn State University
- Study start
- Nov 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 15 Nov 2016 (estimated)
- 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 study aims to improve obstetrical care by managing gestational weight gain (GWG) among high risk women in an effort to reduce maternal and fetal complications.
Detailed description
The project is aimed at teaching women about the appropriate weight gain during pregnancy to optimize health outcomes for mothers and newborn babies. Obese gravida meeting inclusion criteria and none of the exclusion criteria will be offered enrollment in TAGG. Those that consent will be randomized to receive standard of care or enhanced care regarding gestational weight gain.
The primary outcome is the proportion of patients that gain less than 20 lbs over the course of the pregnancy. Secondary outcomes include patient knowledge and expectations, attitude about pregnancy weight gain, self-efficacy of ability to eat healthy, and eating, sleeping and physical activity behavior, perceived stress, psychological factors, patient-experience, involvement in care, and food security.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | No intervention | –Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider. |
| Enhanced Care (EC) | Experimental | Behavioral: Enhanced CareIn addition to standard of care, the study participants will also receive: i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pre-pregnancy body mass index of at least 30 kg/m2 (per patient report of weight)
- Less than 16 weeks gestation
- Gestational weight gain (GWG) less than < 11 pounds from their pre-pregnancy weight to time of potential study enrollment
- Singleton gestation
- Access to a phone
Key exclusion criteria (12 listed)
- BMI less than 30 kg/m2
- Gestational age greater than or equal to 16 weeks
- Active diagnosis of cancer on their electronic health record problem list
- Acquired immunodeficiency syndrome (AIDS)
- Palliative medicine patients
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 |
|---|---|---|
| Enhanced CareAlso: ECIn addition to standard of care, the study participants will also receive: i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy. | Behavioural | Enhanced Care (EC) |
Primary outcome
Gestational weight gain, adjusting for time in the study
Time frame: at delivery
13 secondary outcomes
Patient knowledge and expectations factors
Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Attitude on pregnancy weight gain
Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Self-efficacy of healthy eating
Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Eating, sleeping and physical activity behavior
Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Patient-experience and involvement in care
Time frame: Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
Delivery of large for gestational age infants
Time frame: At Delivery
Diagnosis of gestational diabetes mellitus
Time frame: Baseline through 4-12 Weeks Postpartum
Neonatal intensive care unit (NICU) admissions
Time frame: At Delivery
Cost of Treatment
Time frame: Baseline through 4-12 Weeks Postpartum
Mode of delivery
Time frame: At Delivery
Rate of gestational weight gain
Time frame: Baseline through 4-12 weeks postpartum
Perceived stress measured via Perceived Stress Scale
Time frame: Baseline through 4-12 weeks postpartum
Psychological factors measured via Pregnancy Weight Gain Attitude Scale
Time frame: Baseline through 4-12 Weeks postpartum
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 14 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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.
Awathif D Mackeen, MD, MPH principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Care in people with Obesity, run by Geisinger Clinic 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 12 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 14 Aug 2019. 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?
Gestational weight gain, adjusting for time in the study (time frame: at delivery). 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 14 Aug 2019.