Teaching Appropriate Gestational Weight Gain (TAGG)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Pennsylvania
-
Danville、Pennsylvania、アメリカ、17822
- Geisinger Health System
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Standard of Care (SOC)
Participants will receive the usual standard of care which includes written educational materials as well as counseling by their obstetric care provider.
|
|
|
実験的：Enhanced Care (EC)
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. |
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Gestational weight gain, adjusting for time in the study
時間枠：at delivery
|
at delivery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient knowledge and expectations factors
時間枠：Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
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.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
|
Attitude on pregnancy weight gain
時間枠：Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
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.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
|
Self-efficacy of healthy eating
時間枠：Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
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.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
|
Eating, sleeping and physical activity behavior
時間枠：Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
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.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
|
Patient-experience and involvement in care
時間枠：Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
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.
|
Baseline, 32-34 Weeks Gestation, and 4-12 Weeks Postpartum
|
|
Delivery of large for gestational age infants
時間枠：At Delivery
|
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.
|
At Delivery
|
|
Diagnosis of gestational diabetes mellitus
時間枠：Baseline through 4-12 Weeks Postpartum
|
This measure will be obtained using EHR data and analyzed utilizing clinic data points.
|
Baseline through 4-12 Weeks Postpartum
|
|
Neonatal intensive care unit (NICU) admissions
時間枠：At Delivery
|
At Delivery
|
|
|
Cost of Treatment
時間枠：Baseline through 4-12 Weeks Postpartum
|
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.
|
Baseline through 4-12 Weeks Postpartum
|
|
Mode of delivery
時間枠：At 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.
|
At Delivery
|
|
Rate of gestational weight gain
時間枠：Baseline through 4-12 weeks postpartum
|
Baseline through 4-12 weeks postpartum
|
|
|
Perceived stress measured via Perceived Stress Scale
時間枠：Baseline through 4-12 weeks postpartum
|
Perceived Stress will be measured using the Perceived Stress Scale by Cohen et.
al.
|
Baseline through 4-12 weeks postpartum
|
|
Psychological factors measured via Pregnancy Weight Gain Attitude Scale
時間枠：Baseline through 4-12 Weeks postpartum
|
Psychological factors will be assessed using the Pregnancy Weight Gain Attitude Scale by Palmer et.
al.
|
Baseline through 4-12 Weeks postpartum
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Awathif D Mackeen, MD, MPH、Geisinger Clinic
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。