Multi-site Trial Using SMS to Improve Infant Weight (SMS)
2018年5月24日 更新者：Cristina Palacios、University of Puerto Rico
Multi-site Trial Using Short Mobile Messages (SMS) to Improve Infant Weight in Low-income Minorities
The goals of this multi-site clinical trial are to pilot test weekly SMS sent to parents/caregivers of infants to improve feeding practices and decrease excessive weight gain in infants who are participants of the Women, Infants and Children (WIC) program in Puerto Rico and Hawaii.
The intervention consists of weekly SMS for 4 months to reinforce the feeding messages provided by WIC.
調査の概要
詳細な説明
The goals of this multi-site clinical trial are to pilot test weekly SMS sent to parents/caregivers of infants to improve feeding practices and decrease excessive weight gain in infants who are participants of the WIC program in two distinct locations, Puerto Rico and Hawaii; to assess acceptability and practicality of the intervention; and to assess acceptability of collecting blood spots in future studies.
The investigators will recruit a convenience sample of parent/caregivers of infants 0-2 months participating in the WIC program in Puerto Rico and Hawaii to send weekly SMS for 4 months.
The weekly messages will focus on reinforcing the breastfeeding messages provided by WIC, preventing overfeeding, delaying introduction of solid foods, and delaying and reducing baby juice consumption, which are key issues in low-income populations.
Participants will complete validated questionnaires and anthropometry before and after the trial and results will be compared to the control group (no messages).
Participants will also answer short questions by SMS at different points and an interview at the end of the trial to assess the SMS.
The investigators will assess how many participants agree to collect blood spots in their infants in future studies.
研究の種類
介入
入学 (実際)
202
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
2ヶ月歳未満 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Caregiver age 18 years and older
- owner of a mobile phone with unrestricted SMS capability
- responsible for the care of the infant and willing to actively participate for the full duration of the study.
Exclusion Criteria:
- infants with special diets
- infants with limited mobility
- pre-term birth (<37 weeks)
- small or large for gestational age (birthweight <10th or >90th p)
- inability to consent to participate in the study
- unwillingness to be randomized and not being able to read
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
|---|---|
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実験的：Nutrition messages
The intervention will focus on reinforcing the WIC breastfeeding messages, preventing overfeeding (i.e. using spoon to feed baby, not adding baby food or cereal to bottle, not placing their babies to sleep with a bottle, feeding their babies without distractions, etc), delaying introduction of solid foods, and delaying and reducing baby juice consumption.
Constructs in the transtheoretical model such as self-efficacy and decisional balance will be used to address key determinants of behavior change to ensure relevance to the audience, and will target individuals both at the earlier and later stages of change.
The messages are written at a grade 5 level in Spanish (PR site) and English (Hawaii site) and will be sent on different days and times of the week.
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This is an intervention using short mobile messages (SMS)
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アクティブコンパレータ：General health messages
The control group will receive weekly SMS about general infant's health issues, such as placing the infant on his/her back to sleep, the timeline for immunizations, the proper use of car seats, asthma and other respiratory conditions common among small children, and other health information relevant to infants.
The investigators will follow the same protocol (schedule, length, language, etc.) as for the intervention messages.
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This is an intervention using short mobile messages (SMS)
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Excessive weight gain
時間枠：0-6 months
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Infant weight-for-length percentile will be calculated using the World Health Organization growth charts, as recommended by the Center for Disease Control and Prevention (CDC) for this age.
Excessive weight will be categorized as ≥90th percentile
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0-6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Acceptability of collecting blood spots
時間枠：0-2 months
|
When recruiting participants, the investigators will ask if they agree to participate in collecting a blood spot sample in their infants.
This will be done through a short questionnaire.
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0-2 months
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Acceptability of the intervention - from short SMS
時間枠：0-6 months
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At different points of the trial, participants will be asked to answer short quantitative and qualitative questions sent by SMS about acceptability of the intervention.
All answers to these questions will be summed and assign as "acceptable" if answers were positive 80% or greater of the times.
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0-6 months
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Acceptability of the intervention - from exit interview
時間枠：0-6 months
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Participants will complete a short semi-structured qualitative interview at the end of the trial to provide the opportunity to make open comments about the acceptability of the SMS.
Answers from the interviews will be loaded into a qualitative data analysis software.
Recordings will be transcribed verbatim for content analysis and the team will develop a coding scheme.
Similar codes will be grouped into broader concepts to facilitate the analysis.
Analysis will involve identifying recurring themes based.
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0-6 months
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Practicality of the intervention - from short SMS
時間枠：0-6 months
|
At different points of the trial, participants will be asked to answer short quantitative and qualitative questions sent by SMS about practicality of the intervention.
Answers will be summed and classified as "practical" if answers were positive 80% or greater of the times.
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0-6 months
|
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Practicality of the intervention - from exit interview
時間枠：0-6 months
|
Participants will complete a short semi-structured qualitative interview at the end of the trial to provide the opportunity to make open comments about the practicality of the SMS.
Answers from the interviews will be loaded into a qualitative data analysis software.
Recordings will be transcribed verbatim for content analysis and the team will develop a coding scheme.
Similar codes will be grouped into broader concepts to facilitate the analysis.
Analysis will involve identifying recurring themes based.
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0-6 months
|
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Infant food frequency
時間枠：0-6 months
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This questionnaire includes 52 food items with a brief description on how these were prepared and/or their source (e.g., raw, canned, etc.).
It also includes different portion sizes and information on supplements use.
Using frequency of intake of each food and amount reported for each food, a total amount of each food per day will be calculated.
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0-6 months
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General infant feeding practices
時間枠：0-6 months
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This questionnaire includes questions about type of infant feeding (breast or bottle-feeding), type of milk used, age of stopping breastfeeding (exclusive and partial), age of introduction of juices and solid foods, use of the bottle to sleep baby, methods of feeding babies (i.e. using spoon, adding solids to bottle, etc).
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0-6 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Cristina Palacios, PhD、Associate Professor
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
- Palacios C, Campos M, Gibby C, Melendez M, Lee JE, Banna J. Effect of a Multi-Site Trial using Short Message Service (SMS) on Infant Feeding Practices and Weight Gain in Low-Income Minorities. J Am Coll Nutr. 2018 Sep-Oct;37(7):605-613. doi: 10.1080/07315724.2018.1454353. Epub 2018 Apr 30.
- Banna J, Campos M, Gibby C, Graulau RE, Melendez M, Reyes A, Lee JE, Palacios C. Multi-site trial using short mobile messages (SMS) to improve infant weight in low-income minorities: Development, implementation, lessons learned and future applications. Contemp Clin Trials. 2017 Nov;62:56-60. doi: 10.1016/j.cct.2017.08.011. Epub 2017 Aug 19. No abstract available.
- Gibby CLK, Palacios C, Campos M, Graulau RE, Banna J. Acceptability of a text message-based intervention for obesity prevention in infants from Hawai'i and Puerto Rico WIC. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):291. doi: 10.1186/s12884-019-2446-9.
- Gibby CLK, Palacios C, Campos M, Lim E, Banna J. Associations between gestational weight gain and rate of infancy weight gain in Hawai'i and Puerto Rico WIC participants. BMC Obes. 2018 Dec 3;5:41. doi: 10.1186/s40608-018-0219-z. eCollection 2018.
- Gibby CLK, Palacios C, Campos M, Lim E, Banna J. Breastfeeding Discontinuation Not Associated with Maternal Pregravid BMI But Associated with Native Hawaiian or Other Pacific Islander Race in Hawaii and Puerto Rico WIC Participants. Matern Child Health J. 2019 Jan;23(1):19-29. doi: 10.1007/s10995-018-2587-x.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年1月1日
一次修了 (実際)
2016年8月31日
研究の完了 (実際)
2016年8月31日
試験登録日
最初に提出
2016年5月10日
QC基準を満たした最初の提出物
2016年9月12日
最初の投稿 (見積もり)
2016年9月16日
学習記録の更新
投稿された最後の更新 (実際)
2018年5月29日
QC基準を満たした最後の更新が送信されました
2018年5月24日
最終確認日
2018年5月1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。
SMSの臨床試験
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University of MichiganUniversidad de Los Andes, Bogota, Colombia完了
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University of PittsburghUniversity of Pennsylvania完了
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